Patch pump systems and apparatus for managing diabetes, and methods thereof

Abstract

To provide patch pump systems and apparatus for managing diabetes, and methods thereof.SOLUTION: Embodiments of the current disclosure are directed toward systems, devices and methods for diabetes management. In particular, the present disclosure relates to systems, devices and methods for dispensing insulin to a patient using a miniaturized and portable patch pump. A patch-pump assisting system configured to at least function to insert a cannula into tissue comprises: a housing; a disposable part (DP) of a patch-pump drug delivery system removably affixed to the housing; a notch or opening formed in a side of the housing and configured to receive at least a reusable part (RP) of the patch-pump drug delivery device; at least two safety catches arranged on the housing; and an insertion mechanism configured to insert a cannula upon activation.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Embodiments of the present disclosure are directed to systems, devices, and methods for managing diabetes. More specifically, the present disclosure relates to a portable, small insulin patch pump that can be fixed to the skin for dispensing insulin to a patient.

Background Art

[0002] Diabetic patients need to administer various amounts of insulin throughout the day to control their blood glucose levels. A portable insulin infusion pump for walking can be used as an alternative to insulin injection with a syringe multiple times a day, but such a pump can be bulky and complex to handle.

Summary of the Invention

Means for Solving the Problems

[0003] Embodiments of the present disclosure are directed to a diabetes management system that includes a small insulin patch pump. In some embodiments, an insulin patch pump that can be fixed to the skin and has no tube, like a pager, may be desirable because it is not bulky and avoids tube handling and complications. However, even if the pump is miniaturized, it may be desirable for the patch pump to meet technical specifications and user interface requirements that are at least similar to those of a pager pump. In the discussion of some embodiments in the present disclosure, the insulin is referred to as the drug delivered by the patch pump disclosed herein, but it is to be understood that using the disclosed patch pump for other fluids is within the scope of the embodiments of the invention described herein.

[0004] In some embodiments, the patch pump may be controlled by a handheld controller having wired or wireless communication means, examples of the latter including, but not limited to, RF communication means such as Bluetooth® or Bluetooth® Low Energy (BLE). The patch pump may be integrated into a diabetes management system, including a continuous glucose monitor (CGM) and a blood glucose monitor (BGM). The artificial pancreas algorithm on the patch pump processor can control insulin delivery according to continuous or intermittent glucose measurements received from a remote CGM (“closed-loop system”) (e.g., automatically, when prompted, etc.). The patch pump delivers insulin periodically (e.g., continuously), receives glucose measurements from the CGM, administers insulin accordingly, and may receive bolus commands from the controller during meals. The controller may communicate with a smartphone and / or one or more servers (e.g., via a one-way or two-way communication link to the cloud) so that data from the diabetes management system can be transmitted remotely over the line. As an example, the controller of a patch pump worn by a pediatric patient may transmit various data collected and / or received by the patch pump to the parent's smartphone and / or one or more computer servers of the pediatric patient's healthcare provider.

[0005] In some embodiments, the patch pump can include one or more of: 1) a reusable part (RP) that includes a housing (“RP housing”), a connection magnet / iron plate, one or more power sources such as a battery, a buzzer, a drive mechanism that includes a motor, gears, and a lead screw, in some examples at least a portion of the pump mechanism, and an electronic module that includes a PCB, a microprocessor, and sensors; 2) a disposable part (DP) that includes a housing (“DP housing”), a connection magnet / iron plate, an adhesive base, in some examples at least a portion of the pump mechanism that can include a cannula, a first reservoir and a second reservoir (“doser”), a first plunger and a second plunger, a doser actuator, a conductive conduit, a two-chamber valve mechanism, an inlet, and an outlet (“well”); 3) a filled disposable inserter assembly (which may also be referred to herein as a patch pump support system, and the expression can be used with the same meaning throughout) that includes a housing, a trigger, a safety catch, a cannula insertion mechanism, a release mechanism, and a viewing window; and 4) a charger.

[0006] In some embodiments, the RP includes at least two compartments: a venting compartment that is in air communication with the atmosphere and a sealed compartment. The venting compartment includes a cavity occupied by the first reservoir after RP-DP connection. The sealed compartment includes the drive mechanism, the electronic module, and a cavity that occupies the first reservoir (doser) after RP-DP connection. The drive mechanism includes a motor (e.g., a stepper motor or a DC motor), gears, and a lead screw. A lead screw pin traverses an opening vertically at the tail of the lead screw and can slide freely within a groove of the RP housing. During operation (and rotation) of the motor and gears, rotation of the lead screw can be blocked by the lead screw pin, and as a result, the lead screw moves linearly in one direction. Reversing the rotation direction of the motor and gears reverses the linear movement of the lead screw.

[0007] In some embodiments, the DP includes a pump mechanism and all or substantially all components that come into contact with the fluid to be delivered (e.g., but not limited to, a drug such as insulin), including a reservoir, a two-chamber valve mechanism, conduits, a filling port, and an outlet. The two-chamber valve mechanism (the "valve mechanism") may include an injection chamber and a discharge chamber. The main conduits are a first conduit that communicates between the first reservoir and the injection chamber, and a second conduit that communicates between the discharge chamber and the outlet. In some embodiments, the DP is provided with a sleeve, i.e., a cylinder that is firmly connected to the DP housing and houses the dispenser so that the dispenser can move freely linearly within the sleeve. The sleeve is connected to a sleeve cover that holds the dispenser within the cavity of the sleeve. At least one gasket in proximity to the sleeve (e.g., the O-ring of the RP-DP) may seal the RP-sealing compartment after RP-DP connection.

[0008] In some embodiments, an adhesive base is provided to the DP. The adhesive base includes a bent base having an adhesive upper surface and a bottom surface, a filling hole (filling port) covered with an automatically sealed rubber diaphragm (filling diaphragm), and a cannula hole. The adhesive both sides are covered with a folded removable liner before operation (e.g., before performing RP-DP connection). After RP-DP connection, the liner is removed, the adhesive upper surface adheres to the RP housing, and the adhesive bottom surface adheres to the patient's skin. A firm reversible connection between the RP and the DP can be provided by the force generated simultaneously by the connection magnet and the adhesive upper surface of the adhesive base. The connection magnet and the iron plate can be installed compatibly on the RP and / or the DP.

[0009] In some embodiments, the DP provides a cannula that is inserted into the patient's body after the patch pump is adhered to the skin. The cannula has a sharp tip at the distal end, a cap (cannula cap) at the proximal end, and an opening (cannula opening) in the middle portion of the cannula, and can be rigid or at least substantially rigid (e.g., a steel cannula). The cannula can move linearly within a groove (DP groove) in the DP housing that traverses the DP housing. The DP groove has an upper end, a lower end, and an intermediate portion with a cavity (well). The distal end of the DP groove communicates with the cannula hole in the adhesive base and is sealed with a bottom seal and a bottom spacer. Before insertion, the upper end of the cannula protrudes from the DP housing, so that the cannula cap and the cannula opening are positioned above the DP housing and the sharp tip is positioned within the well. During cannula insertion, the cannula cap aligns with the DP housing, the cannula traverses the bottom seal and the bottom spacer, and the sharp tip of the cannula protrudes below the DP housing through the cannula hole in the adhesive base. After insertion, the cannula opening aligns with the well and provides a hydraulic communication between the discharge chamber and the cannula via a second conduit.

[0010] In some embodiments, the patch pump is operable when the RP and the DP are connected. After the RP-DP connection, the first reservoir is present within the RP venting compartment and the dispenser is present within the RP sealing compartment. The RP and the DP connect firmly and / or reversibly at the following interfaces: 1) the interface between the magnet (DP) and the iron plate (RP) (or vice versa), and 2) the interface between the adhesive (DP) and the RP housing (RP). After use, the DP adhesive is peeled from the RP housing and the magnet-iron plate disengages.

[0011] In some embodiments, a filled, disposable inserter (an inserter system, also known as a patch pump support system) is provided. The inserter can include an inserter housing, an RP notch, a safety catch, a viewing window, a trigger, a DP holder, a pre-loaded spring, a rotating nut having a rotating thread and a dispenser, and a hammer having a linear thread and a cannula pusher. The rotating thread and the linear thread can engage with each other. When the trigger is pressed, the pre-loaded spring rotates the rotating nut, the rotating thread, and the dispenser, the hammer moves linearly in the direction of the skin, and the DP holder moves laterally. The rapid linear movement of the hammer and the hammer cannula pusher inserts the cannula into the body. After insertion, the inserter is removed and the patch pump is ready for operation.

[0012] In some embodiments, the inserter and the DP can be pre-assembled and provided in one sterile blister. The DP adhesive base may be seated on the bottom side of the inserter housing. The RP is inserted into the inserter housing through the RP notch and the RP connects to the DP within the inserter housing. Following the RP-DP connection, the first reservoir is filled through the fill port and the patch pump is primed with controller commands.

[0013] In some embodiments, the first reservoir can be filled with a syringe. After withdrawing fluid (e.g., a drug such as insulin) from the vial, the drug can be injected from the syringe needle through the fill port, into the first conduit, and into the first reservoir. Prior to cannula insertion, activating the pump mechanism by a controller command can automatically purge air bubbles. The fluid is dispensed from the first reservoir to the dispenser (via the conduit and the two - chamber valve mechanism), from the dispenser to the well, from the well to the cannula tip (prior to insertion, the cannula tip is positioned within the well), and from the cannula tip to the cannula opening (prior to insertion, positioned above the DP housing). When the inserter and the DP housing are in the upright position, the trapped air may be purged from the cannula opening before the fluid is dispensed. During priming, the dripping of the fluid can be seen through the viewing window of the inserter. By observing the drops emerging from the cannula opening, the user can be notified that the patch pump is being primed. After priming is complete, the inserter and the patch pump are adhered to the skin, the cannula is inserted, and the inserter is removed from the skin and disposed of.

[0014] In some embodiments, the patch pump is provided with a reversible engagement mechanism between the RP male screw and the DP second plunger. The engagement mechanism provides a reversible and strong connection between the male screw and the second plunger after RP-DP connection, and enables the male screw to separate from the second plunger during RP-DP separation. In some embodiments, the engagement mechanism includes a scraper spring. The scraper spring is firmly or substantially firmly connected to the second plunger and has a flexible scaffold with depressions that can be enlarged or reduced in size. In some embodiments, the scraper spring consists of a plurality of flat ribs (e.g., three flat ribs), and each rib is folded outward in a petal-like shape. In some implementations, the tip of the driving screw has a conical protrusion, and the sleeve cover has a protrusion (the "sleeve cover protrusion"). During RP-DP connection, the conical protrusion of the driving screw (a part of RP) engages at least substantially firmly with the scraper spring (a part of DP). When the second plunger reaches the proximal end of the dispenser, the scraper spring engages with the sleeve cover protrusion, expands slightly, the male screw can be freely disengaged from the scraper spring, and RP can be freely disengaged from DP.

[0015] In some embodiments, the pump mechanism may include a first reservoir, a first plunger, a second reservoir (the dispenser), a second plunger, a two-chamber valve mechanism (the valve mechanism), a first conduit, a second conduit, and a well. The two-chamber valve mechanism includes two chambers, an injection chamber and a discharge chamber, and a slide needle that is at least substantially rigidly connected to the dispenser. The slide needle has a proximal end that is in hydraulically communication with the dispenser, a closed distal end that terminates, and at least one opening at an intermediate point. The first conduit communicates between the first reservoir and the injection chamber (the "first conduit"), and the second conduit communicates between the discharge chamber and the outlet. The first conduit is in hydraulically communication with the fill port. During filling of the first reservoir, fluid is injected into the first reservoir through the fill port and the first conduit (e.g., using a syringe with a needle). The DP outlet (the well) consists of a sealed cavity that communicates with the second conduit. The cavity is sealed with a top seal and a bottom seal. During pump operation, fluid is delivered from the discharge chamber through the second conduit into the well and from the well through a cannula into the patient's body.

[0016] In some embodiments, both the first reservoir and the second reservoir have a proximal end and a distal end. When the reservoir (first and second) is empty, the plunger is positioned at the distal end. While filling the reservoir, the plunger moves in the direction of the proximal end, and when the reservoir is filled to its maximum capacity, the plunger is positioned at its most proximal end. In some embodiments, the first reservoir has a cylindrical shape with a wall and a cavity. The cross-section of the cylinder can be oval, elliptical, four-segmented, circular, or any other symmetric or nearly symmetric configuration. The dispenser and the slide needle may move linearly relative to the first reservoir by the linear movement of the parent screw and the continuous linear movement of the second plunger. When the second plunger moves in one direction, the dispenser and the slide needle move linearly in the same first direction (e.g., the forward direction), and the opening of the slide needle is positioned within the injection chamber. In this delivery phase (drug filling phase), the fluid is delivered from the first reservoir through the first conduit into and into the dispenser within the injection chamber. When the second plunger moves in the opposite direction, the dispenser and the slide needle move linearly in the same opposite direction (e.g., the reverse direction), and the opening of the slide needle is positioned within the discharge chamber. In this delivery phase (dispenser discharge phase), the fluid is delivered from the dispenser through the discharge chamber, through the second conduit to the well, and from the well to the cannula. In some embodiments, the first plunger includes a piston and two gaskets, a first proximal gasket and a second distal gasket. In some embodiments, the plunger is made of a sealing material (e.g., rubber) and comprises a single piece having two circumferential contact surfaces with the first reservoir cavity.

[0017] In some embodiments, a dosing sensor is provided for the patch pump. The linear movement of the second plunger induces two successive movements: first, the movement of the doser relative to the first reservoir and the RP housing, and second, the movement of the second plunger relative to the doser. The patch pump is provided with a sensor (dosing sensor) for detecting the linear movement of the doser relative to the first reservoir and the RP housing. The dosing sensor can be used to at least substantially accurately define the start of fluid delivery (e.g., by calculating insulin dosing) and / or to detect the connection / separation of the RP-DP. When the second plunger moves linearly in one direction by the lead screw, the dispenser moves in the same direction due to the frictional force between the dispenser and the second plunger. When the dispenser reaches a rigid stopper (e.g., the distal end of the sleeve), further movement of the second plunger causes the fluid in the dispenser to move in the same direction (e.g., insulin delivery). In some embodiments, the sensor consists of a photodetector that is rigidly connected to the RP electronic module. The dosing sensor can detect the linear movement of a dosing sticker, which can be a sliding identification means that is rigidly connected to the dispenser and positioned in the line of sight of the photodetector. Non-limiting examples of the identification means can include a barcode consisting of simple rectangular tags (e.g., in equal amounts) that include black and white colors. In such an example, black can be interpreted by the photodetector and converted to a relatively low current (or voltage). At the start of the forward movement of the dispenser, the photodetector is activated by the microprocessor of the electronic module. As the dispenser moves further forward, the black tag gradually occupies the field of view of the window of the photodetector and the output power decreases. When the movement of the dispenser stops, the output voltage remains constant and the microprocessor interprets the signal as indicating that there is no relative movement between the photodetector and the dosing sticker (and no relative movement between the dispenser and the RP housing). The dosing sensor can warn the user of the patch pump in case of improper RP-DP connection and / or inadvertent RP-DP separation during pump operation.

[0018] The operating cycle of the patch pump includes at least two phases: 1) a syringe filling phase and 2) a syringe discharging phase. In the syringe filling phase, fluid is delivered from the first reservoir to the syringe, and in the syringe discharging phase, fluid is delivered from the syringe to the outlet. In the syringe filling phase, the movement of the second plunger within the syringe induces a negative pressure (relative to atmospheric pressure) in the injection chamber, the first conduit, and the first reservoir. Due to the pressure gradient between the atmosphere and the first reservoir, fluid is delivered from the first reservoir to the second reservoir (syringe), and the first plunger moves in the direction of fluid movement. Due to the pressure gradient between the atmosphere and the first reservoir, air enters into the reservoir through the interface between the first plunger and the first reservoir. When air enters into the first reservoir, air bubbles are formed in the delivered fluid (e.g., insulin), and injecting air instead of insulin can put diabetes pump users at risk. Further, during successive delivery cycles, the volume of the air bubbles increases, and the total volume of the air bubbles can occupy a majority of the volume of the first reservoir.

[0019] Embodiments of the present disclosure provide solutions to avoid air ingress into a first reservoir, including active and passive solutions. In the active solution, the relative negative pressure in the first reservoir is actively increased above atmospheric pressure, while in the passive solution, the inflow of air into the first reservoir is at least substantially blocked. In some embodiments of the active solution, when there is fluid communication between the dispenser and the first reservoir, the direction of fluid delivery is reversed at the end of the dispenser filling phase to reduce the negative pressure. Delivery of the flow from the dispenser into the first reservoir increases the pressure in the first reservoir above atmospheric pressure, so that at this time, following the reversal of the pressure gradient from the first reservoir to the outside air, air moves. The reversal of the fluid delivery direction is achieved by reversing the direction of movement of a second plunger (from the filling phase to the discharge phase). At the start of the movement of the second plunger (discharge phase), a doser locker is activated and temporarily locks the dispenser firmly in place. At this stage, the movement of the second plunger causes fluid to move from the dispenser into the first reservoir. When the doser locker stops, the fixation of the dispenser is released and further movement of the second plunger causes the dispenser and the slide needle to move until the opening of the slide needle is positioned in the discharge chamber. At this stage, further movement of the second plunger causes fluid to move from the dispenser into the discharge chamber, the second conduit, the well, the cannula, and into the patient's body. The doser locker can be operated by, for example, a nitinol wire, a solenoid, a piezoelectric actuator, and / or the like. In a nitinol-based doser locker, the nitinol wire is preformed in the form of a spring, and when an electric current is delivered to the spring, the overall length of the spring coil decreases (e.g., as a result of the nitinol contraction phenomenon), and as a result, the doser locker moves and engages with the dispenser. When the electric current stops, the nitinol wire returns to its original length, the doser locker disengages from the dispenser, and the dispenser can move freely.

[0020] In some embodiments of the passive solution, air entry into the first reservoir is blocked by fluid present between two gaskets of the first plunger. The fluid can be, for example, oil or any other high-viscosity fluid that may be injected between the two gaskets. In some embodiments, the fluid is insulin injected between the gaskets during filling of the first reservoir. The first reservoir is provided at its distal end with a circumferential cavity slightly larger than other portions of the reservoir cavity. The first plunger is provided with slots communicating to the outside air, which enable air purge and block the purge of fluid (fluid restrictor). During filling of the first reservoir, the plunger is seated at the distal end of the first reservoir, the fluid first occupies the space between the gaskets, and air is purged to the atmosphere through the fluid restrictor. When the space between the gaskets is completely occupied by fluid, the plunger is moved in the direction of the proximal end of the first reservoir by additional fluid injected into the first reservoir. At this stage of filling the first reservoir, the first gasket of the first plunger abuts against the first reservoir wall, and the seal between the first reservoir cavity and the wall is maintained.

[0021] In some embodiments, the patch pump is provided with a reservoir sensor. The reservoir sensor can include an axial pole magnet that can be attached to the plunger of the first reservoir and two hall sensors that are present in the RP seal section very close to the first reservoir. The hall sensor can be a transducer that changes the output voltage according to the magnetic field. Using a known magnetic field, the distance of the hall sensor from the axial pole magnet (and the plunger of the first reservoir) can be determined, and the relative position of the plunger can be estimated. The axial pole magnet and the plunger move within the first reservoir during filling of the first reservoir and during pump operation. It should be noted that in the discussion of the embodiments in the present disclosure regarding the magnet, although reference is made to the axial pole magnet, the use of any other type of magnet is considered to be within the scope of the embodiments of the invention described herein (and thus not limited to the axial pole magnet).

[0022] In some embodiments, the patch pump fills the first reservoir, inserts the RP into the inserter housing, connects the RP and DP to the magnet / iron plate and the adhesive base, purges the air (primes), adheres the adhesive base to the skin, presses the inserter trigger, inserts the cannula, and is ready for use after disposing of the inserter. At the end of patch pump use (which may be after 2 to 5 days of use in some examples), the pump can be removed from the body by separating the bottom surface of the adhesive base from the skin. After pump removal, the adhesive base can be folded over the cannula to protect the patient from inadvertent self-puncture. Subsequently, the RP is separated from the DP by separating the RP iron plate from the DP magnet (or vice versa). Following RP-DP separation, the RP is placed in a charger to recharge the RP battery for further operating cycles, and the DP is disposed of.

[0023] Some of the advantages of the embodiments of the present disclosure include a small-sized device (thus convenient for carrying), the accuracy of the device, and ease of integration. For example, the device and system may possess the ability to integrate with a closed-loop diabetes management system. Further, it can be utilized for a much longer period than when using conventional systems. Additionally, the present embodiments disclose a method of removing air bubbles from a fluid, i.e., a feature that differentiates these features from conventional methods and systems.

[0024] In some embodiments, a portable device is disclosed that includes an insulin reservoir in communication with a subcutaneous cannula and methods for the sustained (basal) and on-demand (bolus) delivery of insulin. The basal and bolus delivery rates can contribute to improved accuracy of insulin delivery. In some embodiments, a substantially smaller, less bulky, thinner, skin-adherable portable insulin pump (patch pump) is disclosed than previously known insulin delivery systems. Further, the skin-adherable patch pump can be concealed. In some embodiments, the device may not have operating buttons and / or may be remotely controlled. Additionally, the patch pump can be controlled by various consumer electronic devices that can be used by a patient, such as, but not limited to, a smartphone, smartwatch, tablet, and / or PC.

[0025] In some embodiments of the present disclosure, a patch pump support system is disclosed that is configured to at least perform the function of inserting a cannula into tissue. The system includes a housing, a disposable component (DP) of a patch pump drug delivery system that is removably attached to the housing, a notch or opening formed on a side of the housing and configured to receive at least a reusable component (RP) of the patch pump drug delivery device, at least two safety catches disposed on the housing, and an insertion mechanism configured to insert the cannula upon activation.

[0026] The above embodiments (and other embodiments disclosed in the present disclosure) may include at least one or another (or any plurality) of the following features, structures, functionalities, providing further embodiments of the present disclosure. ● The patch pump support system includes a trigger for activating the insertion mechanism. ● When the notch receives the RP, the RP and DP can be connected. ● The patch pump support system includes a release mechanism configured to release the connected DP and RP after activation of the insertion mechanism. ● The DP includes a reservoir, and the housing can be configured to receive an external supply of drug for filling the reservoir via a filling hole. ● The RP of the patch pump includes a motor configured to automatically effect priming of the patch pump upon connection with the DP. ● The cannula is configured with at least two openings, a first opening configured to prime the patch pump and a second opening configured to deliver drug when inserted into tissue. ● The first opening is disposed at or adjacent to the proximal end of the cannula, and the second opening is disposed at or adjacent to the distal end of the cannula, with the distal end being first inserted into tissue. ● The first opening is in fluid communication with the reservoir of the DP. ● The cannula is inserted by simultaneously depressing at least two safety catches by triggering an insertion mechanism. ● The cannula is configured to be inserted through the DP of the patch pump into tissue. ● The patch pump support system may further include a cannula cap configured to seal a groove at the proximal end of the cannula. ● When the cannula is inserted into tissue, the cannula firmly connects to the patch pump and is in fluid communication with the patch pump. ● At least one of the insertion mechanism and the release mechanism includes a pivot rod, a rotating nut, a spring, a trigger, and a hammer. ● The trigger includes a trigger stopper and a rotating nut stopper. ● The rotating nut stopper includes a rotating thread and a dispenser. ● The hammer includes at least one of a hammer linear thread, a hammer lead, and a cannula pusher. ● The rotating thread is configured for engagement with the hammer linear thread. ● Movement of the trigger and the rotating nut stopper enables rotation of the spring and the rotating nut. ● The energy stored in the spring rotates the rotary nut, the rotary thread, and the dispenser. ● Rotation of the rotary nut causes linear movement of at least one of the hammer and the cannula pusher. ● Rotation of the dispenser causes linear movement of one or more DP holders configured to release the system after cannula insertion. ● The patch pump assist system is configured to perform at least one of aligning the RP and DP during connection of the RP and DP, holding the patch pump during at least one of filling, priming, and skin adhesion of the patch pump, and semi-automatically inserting the cannula upon trigger activation. ● The patch pump assist system may include a window configured to provide one or more viewing fields for observing drug release during priming of the patch pump. ● When the trigger is activated, the rotary nut stopper moves linearly and the rotary nut rotates freely around the pivot rod. ● The hammer lead is configured to maintain linear movement of the hammer while moving in the first direction. ● Upon activation of the system, the cannula pusher pushes the cannula in the first direction. The trigger stopper is released by depressing the safety catch or, if not, by moving it. ● The patch pump assist system may further include at least one disposable part (DP) holder configured to hold the adhesive base of the disposable part (DP) of the patch pump in a substantially proper position on the bottom side of the assist system before activation of the insertion mechanism and cannula insertion. ● After the insertion mechanism is activated, the DP holder moves laterally and the adhesive base is released. ● The DP holder is configured to hold the adhesive base in a substantially proper position before activating the insertion mechanism. ● After the insertion mechanism is activated, the DP holder moves laterally to release the adhesive base for removing the assist system. ● The insertion mechanism includes at least a rotating element and a first linear movement element. When the insertion mechanism is activated by a trigger, the rotational movement of the rotating element is converted into a linear movement of the first linear movement element to insert the cannula into the tissue. ● The rotational movement of the rotating element occurs in a first plane, and the linear movement of the first linear movement element occurs in a second plane substantially perpendicular to the first plane. ● The insertion mechanism includes a second linear movement element. By the rotational movement of the rotating element, the first linear movement element in the first plane is linearly moved orthogonally to the rotating surface, and the second linear element in the second plane is linearly moved orthogonally to both the rotating element and the first linear movement element. ● The patch pump support system further includes a liner that is removably attached to the adhesive base.

[0027] In some embodiments of the present disclosure, a method for using a patch pump drug delivery system is disclosed. Such a method may include providing a patch pump drug delivery system having reusable parts (RP) and disposable parts (DP), providing the patch pump support system disclosed above, and receiving the RP of the patch pump such that the RP of the patch pump is connected to the DP of the patch pump via a notch in the support system.

[0028] The above embodiments (and other embodiments disclosed in the present disclosure) may include at least one or other (or any plurality) of the following features, structures, functionalities, method steps, and provide further embodiments of the present disclosure. ● Wrapping the upper and lower sides of the adhesive base of the DP with the liner of the adhesive base. ● Filling the reservoir of the DP of the patch pump with a drug for delivery through the filling hole by the patch pump. ● Priming the patch pump. ● Viewing at least one of the DP, the cannula, and the cannula cap through the window of the support system. ● To observe the dripping of liquid emerging from an opening in the proximal portion of the cannula through the window of the assistance system, and in some embodiments, the cannula is configured to avoid dripping of the drug during priming from one or more first openings disposed on the proximal end of the cannula. ● Connecting the RP to the DP by the motor of the RP automatically initiates priming of the patch pump. ● Removing the liner and adhering the patch pump to the user's skin. ● Simultaneously depressing the trigger and at least two safety catches so as to activate an insertion mechanism for inserting the cannula into the tissue. ● Activating the insertion mechanism so as to effect at least one of insertion of the cannula and detachment of the patch pump.

[0029] It should be understood that all combinations of the foregoing concepts and additional concepts discussed in more detail below (such concepts being non - conflicting with each other) are considered to be part of the inventive subject matter disclosed herein. In particular, all combinations of the subject matter recited in the claims that appear at the end of this disclosure are considered to be part of the inventive subject matter disclosed herein. It should also be understood that any terms explicitly used herein that may appear in any incorporated disclosure should be given the meaning that most closely matches the particular concepts disclosed herein. This specification also provides, for example, the following items. (Item 1) A patch pump assistance system configured to at least perform the function of inserting a cannula into tissue, a housing, a disposable part (DP) of the patch pump drug delivery system removably attached to the housing, a notch or opening formed on a side of the housing and configured to receive at least a reusable part (RP) of the patch pump drug delivery device. At least two safety catches disposed on the housing; An insertion mechanism configured to insert a cannula during startup; a system comprising the same. (Item 2) The system according to item 1, further comprising a trigger for activating the insertion mechanism. (Item 3) The system according to item 1 or 2, wherein when the notch receives the RP, the RP and the DP are connected. (Item 4) The system according to any one of items 1 to 3, further comprising a release mechanism configured to release the connected DP and RP after activation of the insertion mechanism. (Item 5) The system according to any one of items 1 to 4, wherein the DP includes a reservoir, and the housing is configured to receive an external supply of a drug to fill the reservoir through a filling hole. (Item 6) The system according to any one of items 1 to 5, wherein the RP of the patch pump includes a motor configured to automatically prime the patch pump when connected to the DP. (Item 7) The system according to item 6, wherein the cannula is configured with at least two openings, a first opening configured to prime the patch pump and a second opening configured to deliver the drug when inserted into tissue. (Item 8) The system according to item 7, wherein the first opening is disposed at or adjacent to the proximal end of the cannula, the second opening is disposed at or adjacent to the distal end of the cannula, and the distal end is first inserted into tissue. (Item 9) The system according to item 7, wherein the first opening is in fluid communication with the reservoir of the DP. (Item 10) The system according to any one of items 7 to 9, wherein the cannula is inserted by simultaneously pressing the at least two safety catches by triggering the insertion mechanism. (Item 11) The system according to item 10, wherein the cannula is configured to be inserted into the tissue through the DP of the patch pump. (Item 12) The system according to any one of items 7 to 11, further comprising a cannula cap configured to seal a groove at the proximal end of the cannula. (Item 13) The system according to any one of items 1 to 12, wherein when the cannula is inserted into the tissue, the cannula is firmly connected to the patch pump and is in fluid communication with the patch pump. (Item 14) The system according to item 1, wherein at least one of the insertion mechanism and the release mechanism includes a pivot rod, a rotating nut, a spring, a trigger, and a hammer. (Item 15) The system according to any one of items 1 to 14, wherein the trigger includes a trigger stopper and a rotating nut stopper. (Item 16) The system according to item 15, wherein the rotating nut stopper includes a rotating thread and a dispenser. (Item 17) The system according to any one of items 14 to 16, wherein the hammer includes at least one of a hammer linear thread, a hammer lead, and a cannula pusher. (Item 18) The system according to claim 17, wherein the rotating thread is configured for engagement with the hammer linear thread. (Item 19) The system according to any one of items 14 to 18, wherein the movement of the trigger and the rotating nut stopper enables the rotation of the spring and the rotating nut. (Item 20) The system according to items 14 to 19, wherein the energy stored in the spring rotates the rotary nut, the rotary thread, and the dispenser. (Item 21) The system according to item 20, wherein the rotation of the rotary nut causes linear movement of at least one of the hammer and the cannula pusher. (Item 22) The system according to item 20, wherein the rotation of the dispenser causes linear movement of one or more DP holders configured to release the system after cannula insertion. (Item 23) The system aligns the RP and the DP during connection of the RP and the DP; holds the patch pump during at least one of filling, priming, and skin adhesion of the patch pump; is configured to perform at least one of inserting the cannula semi - automatically when the trigger is activated, according to any one of items 1 to 22. (Item 24) The system according to any one of items 1 to 23, further comprising a window configured to provide one or more fields of view for observing drug release during priming of the patch pump. (Item 25) The system according to any one of items 14 to 24, wherein when the trigger is activated, the rotary nut stopper moves linearly and the rotary nut rotates freely around the pivot rod. (Item 26) The system according to any one of items 14 to 25, wherein the hammer lead is configured to maintain linear movement of the hammer while moving in the first direction. (Item 27) The system according to any one of items 14 to 26, wherein when the system is activated, the cannula pusher pushes the cannula in the first direction. (Item 28) The system according to any one of items 14 to 27, wherein the trigger stopper is released by pressing down the safety catch or, if not, by moving it. (Item 29) The system according to any one of items 1 to 28, wherein the system further comprises at least one disposable part (DP) holder, and the DP holder is configured to hold the adhesive base of the disposable part (DP) of the patch pump at a substantially proper position on the bottom side of the support system before activation of the insertion mechanism and cannula insertion. (Item 30) The system according to item 29, wherein after the insertion mechanism is activated, the DP holder moves laterally and the adhesive base is released. (Item 31) The system according to any one of items 29 to 30, wherein the DP holder is configured to hold the adhesive base at a substantially proper position before activating the insertion mechanism. (Item 32) The system according to item 31, wherein after the insertion mechanism is activated, the DP holder moves laterally to release the adhesive base in order to remove the support system. (Item 33) The system according to any one of items 1 to 14, wherein the insertion mechanism comprises at least a rotating element and a first linear moving element, and when the insertion mechanism is activated by the trigger, the rotational movement of the rotating element is converted into a linear movement of the first linear moving element to insert the cannula into the tissue. (Item 34) The system according to item 33, wherein the rotational movement of the rotating element occurs in a first plane, and the linear movement of the first linear moving element occurs in a second plane substantially perpendicular to the first plane. (Item 35) The system according to any one of items 33 to 34, wherein the insertion mechanism includes a second linear moving element, and the rotational movement of the rotating element linearly moves the first linear moving element in the first plane perpendicular to the rotation plane, and linearly moves the second linear element in the second plane perpendicular to both the rotating element and the first linear moving element. (Item 36) The system according to any one of Items 29 to 35, further comprising a liner that is removably attached to the adhesive base. (Item 37) A method for using a patch pump drug delivery system, comprising: providing a patch pump drug delivery system having reusable parts (RP) and disposable parts (DP); providing an assistance system according to any one of Items 1 to 37; receiving the RP of the patch pump through the notch of the assistance system so that the RP of the patch pump is connected to the DP of the patch pump. (Item 38) The method according to Item 37, further comprising wrapping upper and lower sides of the adhesive base of the DP with the liner / liner of the adhesive base. (Item 39) The method according to any one of Items 37 to 38, further comprising filling a reservoir of the DP of the patch pump with a drug for delivery through a filling hole of the patch pump. (Item 40) The method according to any one of Items 37 to 39, further comprising priming the patch pump. (Item 41) The method according to any one of Items 37 to 40, further comprising viewing at least one of the DP, the cannula, and the cannula cap through a window of the assistance system. (Item 42) The method according to any one of Items 37 to 40, further comprising viewing dripping of a liquid emerging from an opening in a proximal portion of the cannula through a window of the assistance system. (Item 43) The method according to any one of Items 37 to 42, further comprising automatically starting priming of the patch pump when the RP is connected to the DP by a motor of the RP. (Item 44) The method according to any one of items 37 to 43, wherein the cannula is configured to avoid dripping of the drug during priming from one or more first openings disposed on the proximal end of the cannula. (Item 45) The method according to any one of items 37 to 44, further comprising removing the liner and adhering the patch pump to the user's skin. (Item 46) The method according to any one of items 37 to 45, further comprising simultaneously depressing the trigger and the at least two safety catches so as to activate the insertion mechanism for inserting the cannula into tissue. (Item 47) The method according to any one of items 37 to 45, further comprising activating the insertion mechanism so as to effect at least one of insertion of the cannula and detachment of the patch pump.

Brief Description of the Drawings

[0030] Those skilled in the art will understand that the drawings are mainly for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily to scale, and in some instances, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to make the various features easier to understand. In the drawings, the same reference numerals generally refer to the same features (e.g., elements that are functionally and / or structurally similar).

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Mode for Carrying Out the Invention

[0070] FIG. 1 shows an illustration of a diabetes management system 1000 according to some embodiments. The system includes at least one of the following components: insulin patch pump 1, controller 2, smartphone 8, continuous glucose monitor (CGM) 3, blood glucose monitor (BGM) 4, and cloud of servers 7. The components of system 1000 may be configured to communicate with each other via one-way and / or two-way communication channels. For example, two-way communication may occur between pump 1 and controller 2, while one-way communication may occur between pump 1 and smartphone 8 (e.g., from the pump to the smartphone) or between pump 1 and cloud 7 (e.g., from the pump to the cloud). The communication protocol may be one or more of Bluetooth®, Bluetooth® Low Energy (BLE), WiFi®, and any other RF protocol (including proprietary protocols) such as, but not limited to, RFID. Pump controller 2 may provide a user interface with pump 1 to command basal and bolus dosages as well as profiles and to receive warnings, alerts, log files, etc. Communication between CGM 3 and pump 1 may provide the functionality of an artificial pancreas (closed-loop system 5) in which insulin dosages are automatically administered according to the glucose values monitored by CGM 3 and algorithm 6. Measurements transmitted from BGM 4 and / or CGM 3 to pump controller 2 and / or smartphone 8 provide the user with glucose measurements for calculating insulin dosages. Real-time data as well as stored data from pump 1, pump controller 2, CGM 3, and BGM 4 may be transmitted to smartphone 8 for presentation or storage. Two-way mobile communication between smartphone 8 and cloud 7 may provide the patient with the ability to download personal data stored on a remote server. Data in cloud 7 may be downloaded, processed, and transmitted from and to a PC, a remote smartphone, or any other consumer product capable of BLE or wireless communication.

[0071] Figure 2 shows the top-level components of an insulin delivery system 2000 according to some embodiments. The system 2000 can include a patch pump 1, a controller 2, an inserter 300 (referred to throughout this disclosure as a patch pump support system in the same sense) for inserting an insulin delivery cannula into subcutaneous tissue, and a charger 400 for charging an RP power source such as a battery. In some embodiments, the length of the patch pump 1 ranges from about 30 mm to about 50 mm, from about 32 mm to about 45 mm, from about 35 mm to about 40 mm, i.e., about 37 mm, and can include values and sub-ranges therebetween. In some embodiments, the width of the patch pump 1 ranges from about 20 mm to about 40 mm, from about 24 mm to about 36 mm, from about 22 mm to about 32 mm, i.e., about 30 mm, and can include values and sub-ranges therebetween. In some embodiments, the height of the patch pump 1 ranges from about 4 mm to about 20 mm, from about 6 mm to about 14 mm, from about 8 mm to about 12 mm, i.e., about 10 mm, and can include values and sub-ranges therebetween. In some embodiments, the weight of the patch pump 1 (including the weight of a fluid drug such as insulin when filled) ranges from about 0.2 oz to about 1 oz, from about 0.3 oz to about 0.8 oz, from about 0.4 oz to about 0.6 oz, i.e., about 0.56 oz, and can include values and sub-ranges therebetween.

[0072] Figures 3A-C show the patch pump 1 before RP-DP connection (Figure 3A), after RP-DP connection (Figure 3B), and after removal of the inserter 300 (Figure 3C) according to some embodiments. The patch pump 1 consists of a reusable part (RP) 10 and a disposable part (DP) 100.

[0073] Figure 4 shows the main components of RP10 and DP100 according to some embodiments. RP10 may include a housing 20 and at least two compartments including a ventilation compartment 22 and a sealed compartment 21. The RP drive mechanism may include a motor 42 and a lead screw 41. DP100 may include a housing 110, a front foil 111, a first reservoir 120, a second reservoir (dispenser) 130, and an adhesive base 190. Before RP-DP connection, the adhesive base 190 may be covered with a removable liner 197.

[0074] Figure 5 shows the assembly of DP100 into inserter 300 according to some embodiments. The DP includes a first reservoir 120, a dispenser 130, and an adhesive base 190. The inserter 300 includes a trigger 320, a safety catch 330, and an RP notch 312. After the assembly process (dotted arrow) of DP100 into the inserter 300, the adhesive base 190 is seated on the bottom side of the inserter 300. In some embodiments, a filling syringe 500 is provided. The syringe 500 is used to draw fluid (e.g., insulin) from a vial and fill the first reservoir 120 using an injection needle 510. In some embodiments, the assembled inserter-DP and syringe 500 are provided within a single sterile blister (not shown).

[0075] Figure 6 shows the components of a charger 400 including a charging adapter 410, a USB plug 420, and an electrical plug 430 according to some embodiments. In some embodiments, the insulin delivery system may include multiple RPs. For example, the insulin delivery system may include two RP10s, and in such embodiments, while one RP10 is operating, the second RP10 is connected to the charger 400 for battery charging. The battery can be charged with any other connector (USB, micro-USB, pin connector, etc.) that can be plugged directly into the RP.

[0076] Figure 7 shows some of the main components of RP10 according to some embodiments. The RP housing (20, not shown) is composed of an RP cover 25 and an RP base 24. The RP cover 25 includes a buzzer 90 embedded in the RP cover 25 and an upper RP groove 23. The RP base 24 includes two embedded charging pads 224 (bottom side), a bottom RP groove 231, a dispenser sensor socket 631, a reservoir sensor socket 1 of 641, and a reservoir sensor socket 2 of 642. RP10 includes a drive mechanism 40, an electronic module 60, and a battery 80. The drive mechanism 40 includes a motor 42, a motor cover 442, a lead screw 44, and a lead screw pin 45. The lead screw pin 45 slides freely within the bottom RP groove 23 and the upper RP groove 231 and prevents the rotation of the drive screw 44 during the operation of the motor 42. The electronic module 60 may include a PCB 61, a dispenser sensor 63, and an encoder sensor 66.

[0077] Figure 8 shows an exploded view of some components of the drive mechanism 40 including a gear 43, a motor 42, and a lead screw 44 according to some embodiments. The drive mechanism base 41 is a chassis that aligns three mating spur gears, namely a pinion 431, an idler 433, and a rotating nut 435. The three mating spur gears can be protrusions, or helices, or any other type. The pinion cover 432 holds the pinion 431 in place. In some embodiments, a bearing 436 provides free rotation of the rotating nut 436 within the drive mechanism base 41 and the idler 433 pivots around the idler shaft 434. The lead screw 44 includes a lead screw tip 441, a lead screw tail 445, a lead screw protrusion 443, and a lead screw opening 444. The lead screw 44 engages with the rotating nut 425. In some embodiments, the lead screw pin 45 crosses the lead screw opening 444 vertically and prevents the rotation of the lead screw 44 during the operation of the motor 42. By the operation of the motor 42, the pinion 431, the idler 433, and the rotating nut 435 may rotate, and the lead screw 44 may linearly move in one direction. By reversing the turning direction of the motor 42, the lead screw 44 can linearly move in the opposite direction.

[0078] Figure 9 shows a spatial view of the assembled drive mechanism 40 according to some embodiments. The drive mechanism 40 includes a drive mechanism base 41 that serves as a chassis for the motor 42, the assembled gear 43, and the lead screw 44. The gear includes a pinion 431, an idler 433, a rotating nut 435, and a rotating nut bearing 436. A motor sensor (encoder) 46 is attached to the pinion 431. The lead screw 44 engages with the rotating nut 435 and includes a lead screw tip 441 and a lead screw protrusion 443. The rotation of the lead screw 44 is prevented during the operation of the motor 42 and the gear 43 by a lead screw pin 45.

[0079] Figures 10A - B show longitudinal sectional views of the drive mechanism 40 without (Figure 10A) and with (Figure 10B) the lead screw 44 according to some embodiments. The drive mechanism base 41 supports the motor 42, the pinion 431, the pinion cover 432, the idler 433, the rotating nut 435, the bearing 436, and the encoder 46. The lead screw 44 engages with the rotating nut 435 (Figure 10B) and includes a lead screw tip 441, a lead screw tail 445, and a lead screw opening 444.

[0080] Figures 11A - B show a sectional view (Figure 11A) and a spatial view (Figure 11B) of the RP10 according to some embodiments. The RP10 consists of an RP housing 20 and is divided (dashed line) into at least two compartments including a ventilation compartment 22 and a sealed compartment 21. The ventilation compartment 22 includes a cavity 222 that occupies the first reservoir of the DP, and the sealed compartment 21 includes a cavity 221 that occupies the second reservoir of the DP (after RP - DP connection). The sealed compartment 21 has an opening (the opening 26 of the sealed compartment), and the opening 26 can be sealed by a DP - RP O - ring (Figure 12) after RP - DP connection. The sealed compartment 21 includes the motor 42, the gear 43, the battery 80, and lead screws 44a - b. The lead screws (44a - b) are shown in the most forward (distal) position 44a and the rearward (proximal) position 44b. The magnet / iron plate 70 is attached to the motor cover 442 and provides a firm interface with the DP magnet / iron plate.

[0081] FIG. 12 shows a spatial view (bottom side) of some of the components of the DP100 according to some embodiments. The DP100 includes a housing 110, a first reservoir 120, a second reservoir (syringe) 130, a sleeve 171, a filling port 180, and a cannula 200. In some embodiments, the cannula is robust (steel cannula) and has a sharp tip 201. The first reservoir 120 has a first plunger 121, a proximal end 1221, and a distal end 1222. The syringe 130 (covered by the sleeve 171) is movable freely within the sleeve 171. The sleeve 171 has a sleeve cover 173 and is surrounded by an O-ring 170 for the DP-RP.

[0082] Figure 13 shows an exploded space diagram of some of the components of the DP100 according to some embodiments. The DP100 includes a housing 110, a front foil 111, an opening (DP opening 178), and an adhesive base 190. A DP groove (showing the upper end 1121) traverses the DP housing 110 and occupies the cannula 200 before and after insertion of the cannula 200. The cannula 200 includes at least one opening 118 (hereinafter, "cannula opening"). The DP cluster includes a cannula spacer 119 (also "upper spacer" or "upper cannula spacer" in the same sense), a top seal 113, a bottom seal 114, and a bottom spacer 116. The cannula opening 118 is positioned above the DP cluster before insertion and within the DP groove after insertion. The filling port (bottom side, not shown) includes a filling diaphragm 182 and a diaphragm cover 183. The first reservoir 120 includes a plunger 121 consisting of a piston 122 and a gasket 124. The first reservoir has the shape of a cylinder with a cross-section that can be oval, elliptical, four-arc-shaped, circular, or any other symmetric or substantially symmetric configuration. In some embodiments, the plunger 121 may include two or more gaskets 124 and / or may consist of a piece made of an airtight material (e.g., rubber, EPDM, bromobutyl, and / or the like) having at least one circumferential contact point with the first reservoir 120. The second reservoir (dispenser) 130 includes a second plunger (dispenser plunger) 131 consisting of a dispenser piston 132, a dispenser gasket 134, a sticker 145 (barcode for dispenser sensor), a scraper spring 175 (reversible connector with RP male thread), and a slide needle 140. The second reservoir 130 can move linearly within a sleeve 171 that connects to a sleeve cover 173 and a circumferential gasket, i.e., the DP-RP O-ring 170. The sleeve 171 is connected to the DP opening 178 by screw engagement, gluing, and / or welding.

[0083] Figure 14 shows an exploded space diagram of some of the components of the DP100 according to some embodiments. The DP housing 110 includes a first reservoir 120, the upper end of the DP bush 1121, and the DP opening 178. The pre-assembled parts of the dispenser 130, the sleeve 171, and the two-chamber valve mechanism 160 are shown from left to right as follows: the sleeve components of the sleeve 171, the sleeve cover 173, and the DP-RP O-ring 170, the dispenser 130, the spring scraper 175, the dispenser piston 132, the dispenser plunger 134, the dispenser sticker 145, and the slide needle 140 of the dispenser components, and the front spacer 163, the seal 4 of 164, the rear spacer 165, and the seal 2 of 166 of the two-chamber valve mechanism 160.

[0084] Figure 15 shows a longitudinal cross-sectional view (through the dispenser 130) of the assembled DP100 according to some embodiments. The cannula 200 is connected to the DP housing 110. The dispenser 130 consists of a dispenser wall 1334, a dispenser cavity 1333, and a slide needle 140 that is in hydraulic communication with the dispenser cavity 1333. The dispenser plunger 131 consists of a dispenser piston 132, a dispenser gasket 134, and a scraper spring 175. The dispenser plunger 131 can move linearly within the dispenser 130. The dispenser 130 can move linearly within the sleeve 171 and the sleeve cover 173. The sleeve cover 173 includes a sleeve protrusion 174 that engages with the scraper spring 175 when the plunger 131 is in a proximal position (e.g., the most proximal position). The DP-RP O-ring 170 surrounding the sleeve 171 seals the RP sealing compartment after the DP-RP connection.

[0085] Figures 16A - B show longitudinal cross-sectional views of the DP100 (rear view: Figure 16A, front view: Figure 16B) according to some embodiments. The first reservoir 120 consists of a reservoir wall 126, a cavity 127, and a first conduit - first reservoir passage 1551. The DP housing 110 includes a groove 112 of the DP cannula, a filling port 180, and the DP opening 178. Figure 16B shows the first conduit 150, the second conduit 151, and the first conduit - first reservoir passage 1551.

[0086] FIG. 17 shows a front cross-sectional view of an insulin delivery conduit according to some embodiments. The first conduit 150 communicates between the first reservoir and the injection chamber of the valve mechanism (FIGS. 59-62). The second conduit 151 communicates between the discharge chamber of the valve mechanism and the outlet (well). During the medicator filling phase (FIG. 55), insulin is delivered from the first reservoir, through the first conduit - first reservoir passage 1501, and through the first conduit - injection chamber passage 1502, into the injection chamber. During the medicator discharge phase (FIG. 56), insulin is delivered from the discharge chamber, through the discharge chamber - second conduit passage 1511, through the second conduit 151, and through the delivery conduit 153, into the outlet. The filling conduit 152 communicates between the filling port and the first conduit 150. During filling of the first reservoir, a fluid such as insulin can be delivered through the filling conduit 152, through the first conduit 150, and through the first conduit - first reservoir passage 1501, into the first reservoir.

[0087] FIGS. 18A - B show longitudinal cross-sectional views according to some embodiments, through the grooves and outlet of the DP cannula (FIG. 18A), and through the filling port (FIG. 18B). FIG. 18A shows the cannula 200, cannula cap 50, cannula spacer 119, upper seal 113, bottom seal 114, and bottom spacer 116. Insulin is delivered through the delivery conduit 153 into the well 115, and from the well 115 through the cannula 200 into the patient. FIG. 18B shows the filling port 180, which includes the filling hole 181, filling diaphragm 182, and diaphragm cover 183. During filling of the first reservoir, an injection needle (FIG. 5) is introduced through the filling diaphragm 182, and insulin is delivered through the filling conduit 152 to the first reservoir (through the first conduit).

[0088] Figures 19A - D show the spatial view (Figs. 19A and 19B) and longitudinal sectional view (Figs. 19C and 19D) of the DP100 before (Figs. 19A and 19C) and after (Figs. 19B and 19D) the insertion of the cannula 200, according to some embodiments. The DP includes the DP housing 110, the first reservoir 120, the dispenser 130, the adhesive base 190 (cover with liner 197), and the upper end of the groove 1121 of the DP cannula. Before the insertion of the cannula 200, the cannula cap 50 is placed above the DP housing 110. After insertion, the cannula cap 50 is aligned with the upper side portion of the DP housing 110.

[0089] Figures 20A - B show the longitudinal sectional view through the tuft 112 and the filling conduit 153 of the DP cannula before (Fig. 20A) and after (Fig. 20B) the insertion of the cannula 200, according to some embodiments. The groove 112 (dashed rectangle) of the DP cannula includes the cannula spacer 119, the top seal 115, the well 115, the bottom seal 114, and the bottom spacer 116. The cannula 200 includes the cannula cap 50, the cannula opening 118, and the cannula tip 117. Before the insertion of the cannula 200, the cannula cap 50 and the cannula opening 118 are placed above the DP groove 112. After the insertion of the cannula 200, the cannula cap 50 is present within the DP groove 112, and the cannula opening 118 is present within the well 115.

[0090] Figures 21A - D show cross - sectional views of a DP groove according to some embodiments. Figure 21A shows the upper end 1121 of the DP groove, the lower end 1122 of the DP groove, the upper seal 113, and the lower seal 114. Both the upper seal 113 and the lower seal 114 are coin - like in shape and made of a flexible elastomer (e.g., rubber, silicone, etc.). The well 115 is a sealed compartment in fluid communication with the delivery conduit 153. Figure 21B shows the cannula spacer 119 and the lower spacer 116. Both spacers are cylinder - like in shape and made of a flexible elastomer (e.g., rubber, silicone, etc.). Figures 21C and 21D show the cannula 200 within the DP groove before (Figure 21C) and after (Figure 21D) insertion. The cannula 200 includes a cannula cap 50 and a cannula opening 118.

[0091] Figures 22A - B show cross - sectional views of the DP groove during priming (Figure 22A) and operation (Figure 22B) according to some embodiments. The DP stack includes a cannula spacer 119, an uppermost seal 113, a bottom seal 114, a bottom spacer 116, and a well 115. The well 115 is in hydraulic communication with the filling conduit 153. The cannula 200 includes a cannula cap 50, a cannula opening 118, and a cannula tip 117. During priming (Figure 22A), the cannula tip 117 is positioned within the well 115, and the cannula opening 118 and the cannula cap 50 are positioned above the DP housing 110. Insulin is delivered through the delivery conduit 153 into the well 115 and from the well 115 through the cannula 200 into the opening 118. Priming is performed when the patch pump is in the upright position. Priming continues until drops of insulin are seen emerging from the cannula opening 118 and there is no residual air in the system. During pump operation (Figure 22B), the cannula opening 118 is positioned within the well 115, and the cannula tip 117 is positioned below the DP housing 110. Insulin is delivered through the delivery conduit 153 into the well 115 and from the well 115 through the cannula 200 to the cannula tip 117 and into the patient's body.

[0092] Figure 23 shows a spatial diagram of RP10 and DP100 according to some embodiments. The thick dashed double arrow indicates the direction of RP-DP connection and separation. The thin line of the double arrow indicates the proximal and distal directions of the patch pump components and elements.

[0093] Figures 24A - B show a plan sectional view of the patch pump 1 according to some embodiments. The patch pump 1 may include a first reservoir 120, a second reservoir 130, a drive mechanism 40, a valve mechanism 160, a battery 80, a motor 42, and an adhesive base 190. The dashed line (Figure 24A) indicates the boundary of the RP sealing section.

[0094] Figure 25 shows an illustration of the RP-DP interface and the pump mechanism 600 after RP-DP connection according to some embodiments. In some embodiments, the pump mechanism 600 includes an RP male screw 44 and a DP dispenser 130, a valve mechanism 160, a dispenser plunger 131, and a scraper spring 175. Such examples may include embodiments in which the pump mechanism 600 or at least a part thereof is included in the RP only, the DP only, or both the RP and the DP. In some embodiments, the dispenser 130 consists of a wall 1334 and a cavity 1333. The dispenser plunger 131 is firmly connected to the scraper spring 175. The male screw 44 is reversibly connected to the scraper spring 175.

[0095] Figures 26A - C show a spatial diagram (Figure 26A) and sectional views (Figures 26A and 26B) of the magnet 70 and the iron plate 701 before (Figure 26A) and after (Figures 26B and 26C) RP-DP connection according to some embodiments. The magnet 70 provides a removable and firm connection between the RP housing 20 and the DP housing 110. The magnet 70 is firmly connected to the DP housing 110, and the iron plate is firmly connected to the motor cover 442 covering the motor 42. After RP-DP connection, the magnet 70 and the iron plate 701 are in contact with each other. The magnet 70 and the iron plate 71 can be exchanged in position compatibly.

[0096] Figures 27A - B show enlarged illustrations of magnet 70 and iron plate 701 before (Figure 27A) and after (Figure 27B) RP - DP separation according to some embodiments. The iron plate 701 is firmly connected to the motor cover 442, and the magnet 70 is firmly connected to the DP housing 110. The dashed arrows indicate the direction of movement during separation.

[0097] Figure 28 shows a spatial view of the adhesive base 190 according to some embodiments. The adhesive base 190 consists of a bent base 191, a fold line 196, a filling hole 181, and a cannula hole 193. The bent base 191 includes two adhesive surfaces (indicated by dashed arrows), an upper adhesive surface 194 and a bottom adhesive surface 195. Both adhesive surfaces (194 and 195) are covered by a folded liner 197. The liner 197 can be removed by grasping the liner flange 198 and peeling the liner 197 from the bottom adhesive base surface 195 and the upper adhesive base surface 194. The bent base 191 can be folded along the pivot fold line 196. The upper adhesive base surface 194 provides a removable and secure connection between the DP and the RP. The bottom adhesive base surface 195 provides a removable and secure connection between the patch pump and the skin.

[0098] Figures 29A - B show spatial views of the DP 100 without (Figure 29A) and with (Figure 29B) the cannula 200 (before insertion) according to some embodiments. The DP 100 includes a first reservoir 120, a dispenser 130, a bent base 191, a liner 197, a liner flange 198, and a cannula 200.

[0099] Figures 30 - 34 illustrate a continuous process of handling a patch pump including RP - DP connection, liner removal, cannula insertion, patch pump removal, bending of the flexure base, and RP - DP separation. For example, in some embodiments, FIGS. 30A - D and 31A - C illustrate spatial views of handling the patch pump 1 including RP - DP assembly, liner peeling, skin adhesion, and cannula insertion. FIG. 30A shows the assembled inserter 300 with the DP (showing the reservoir 120) attached to the bottom side of the inserter (see FIGS. 35 - 43 for details). The liner 197 covers both sides of the adhesive base 190 (hidden and presented by dashed lines). FIG. 30B shows RP10 being inserted into the inserter 300 in the direction of the dashed arrow. FIG. 30C shows RP10 within the inserter 300 (RP and DP are connected). The peeling of the liner 197 starts by grasping the liner flange 198. FIG. 30D shows the ongoing peeling of the liner 197, where the liner 197 is partially removed from the lower surface of the adhesive base (hidden). FIG. 31A shows the next stage of peeling of the liner 197, where the liner 197 is removed from the bottom surface 195 of the adhesive base (hidden and shown by dashed lines) and still covers the upper surface 194 of the adhesive base. FIG. 31B shows the inserter 300 and the patch pump (partially hidden) after the liner 197 has been completely removed from both adhesive base surfaces (194 and 195). At this stage, the upper surface 194 of the adhesive base adheres to the RP, providing a removable and secure connection between the RP and the DP. FIG. 31C shows the inserter 300 on the skin (thin dashed rectangle), with the bottom surface of the adhesive base adhering to the skin and the trigger 320 being pushed (thick dashed arrow) for cannula insertion.

[0100] Figures 32A - F, 33A - E, and 34A - C show spatial and cross - sectional views of the handling of the pump after removal from a patient's skin, according to some embodiments. Figures 32A and 32B show the patch pump 1, cannula 200, and flexure base 191 after removal of the pass - through pump 1 from the skin. Figure 32C shows the start of the folding of the flexure base 191, where the adhesive base bottom surface 195 is folded in the direction of the cannula 200 and pivots around the fold line 196. Figures 32D - F further show the folding of the flexure base 191, where the adhesive base top surface 194 moves away from the RP housing 20. Figures 33A - E show further folding of the flexure base 191 and the connection of the cannula 200. When the folding of the flexure base 191 is complete, the adhesive base bottom surface 195 covers the connected cannula 200, hiding the cannula 200 and protecting the user from accidental self - puncture. Figures 34A - C show longitudinal cross - sectional views of the DP - RP separation stage after completion of the folding of the flexure base 191. RP10 separates from DP100 (in the direction of the thick dashed arrow) (Figures 34A - B). After RP - DP separation (Figure 34C), RP is recharged and DP is disposed of.

[0101] Figures 35-44 show the inserter 300, inserter activation, and inserter operation, including inserter components, operating mechanisms, and user interfaces, according to some embodiments. In some embodiments, the inserter 300 is provided pre-charged. The inserter 300 provides one or more of the following functions: 1 - alignment of the RP and DP during RP-DP connection, 2 - patch pump holder during filling, priming, and skin adhesion, 3 - semi-automatic cannula insertion (when the trigger is pressed). After cannula insertion, the inserter 300 is automatically discharged from the patch pump and disposed of. For example, in some embodiments, Figure 35 shows a spatial view of the main components of the inserter 300. The inserter includes a housing 310, an RP notch 312, a trigger 320, and two safety catches 330 on both sides of the inserter housing 310. The RP notch provides access to the RP during RP-DP connection. The insertion mechanism 341 and the discharge mechanism 340 include a pivot rod 350, an inserter rotating nut 360, an inserter spring 370, a trigger 320, and an inserter hammer 380. The trigger 320 includes a trigger stopper 362 and an inserter rotating nut stopper 364. The inserter rotating nut 360 includes a rotating thread 361 (hidden, dashed arrow) and a dispenser 363. The inserter hammer 380 includes a hammer linear thread 381, a hammer lead 382, and a cannula pusher 383. When the inserter components are assembled, in some embodiments, the rotating thread 361 engages with the hammer linear thread 381. By pressing both safety catches 330, the trigger stopper 362 is released, and when the trigger 320 is pressed simultaneously, the trigger 320 can move downward. When the trigger 320 and the inserter rotating nut stopper 364 move downward, the free rotation of the inserter spring 370 and the inserter rotating nut 360 becomes possible. The energy stored in the pre-loaded inserter spring 370 rotates the inserter rotating nut 360, the rotating thread 361, and the dispenser 363.The rotation of the inserter rotation nut 361 is converted into a linear movement downward of the hammer 380 and the cannula pusher 383, and as a result, the cannula is inserted into the body. The rotation of the dispenser 363 is converted into a linear movement in the lateral direction of the DP holder (311, not shown in FIG. 35), and after the cannula is inserted, the inserter 300 is released freely.

[0102] FIGS. 36A - B show a spatial view of the inserter 300 according to some embodiments. The inserter 300 includes a housing 310, a trigger 320, a safety catch, an RP notch 312, and a viewing window 390. The viewing window 390 provides a line of sight for observing the dripping of insulin during priming of the patch pump.

[0103] FIGS. 37A - C show a spatial view of the insertion mechanism according to some embodiments. The insertion mechanism includes a trigger 320, an inserter spring 370, an inserter rotation nut 360, a pivot rod 350, and a hammer 380. The trigger 320 includes trigger stoppers 362 (on both sides) and an inserter rotation nut stopper 364. The inserter rotation nut 360 includes a rotation thread 361 and a dispenser 363. The hammer includes hammer leads 382 (on both sides) and a cannula pusher 383. FIGS. 37A and 37B show the insertion mechanism before the trigger 320 is pushed. FIG. 37C shows the insertion mechanism after the trigger 320 is pushed in the direction of the thick dashed arrow. The inserter rotation nut stopper 364 moves linearly in the direction of the thick dashed arrow, and the inserter rotation nut 360 rotates freely around the pivot rod 350.

[0104] Figures 38A - B show a bottom - plane cross - sectional view (Figure 38A) and a top - plane cross - sectional view (Figure 38B) of inserter 300 according to some embodiments. Figure 38A shows inserter hammer 380, which includes hammer leads 382 (both sides) and cannula pusher 383. The hammer leads maintain the linear movement of hammer 380 while it moves downward. When the inserter is activated, cannula pusher 383 pushes the cannula downward. Trigger 320 includes trigger stoppers 362 (both sides), which are released by pressing safety catch 320. DP holder 311 (both sides) holds the DP adhesive base in place at the bottom side of the inserter before inserter activation and cannula insertion. After inserter activation, DP holder 311 moves laterally and the DP adhesive base is released (Figure 41). Figure 38B shows inserter housing 310, trigger 320, and safety catches 330 (both sides).

[0105] Figure 39 shows a spatial view of the bottom side of inserter 300 and DP100 (with part of adhesive base 190 removed) inside inserter 300 according to some embodiments. Inserter 300 includes housing 310, hammer 380, safety catch 330, and DP holder 311 (both sides). DP100 includes first reservoir 120, dispenser 130, filling hole 181, and cannula hole 193. DP holder 311 holds DP adhesive base 190 in place before activation of inserter 300. After inserter activation, DP holder 311 moves laterally (Figure 41), releasing DP adhesive base 190 and enabling free removal of the inserter.

[0106] Figure 40 shows a cross-sectional view of the inserter 300 and the DP100 according to some embodiments. The inserter includes a trigger 320, an inserter rotating nut 360, a rotating thread 361, an inserter spring 370, a pivoting rod 350, an inserter hammer 380, a cannula pusher 383, and a liner thread 381. The DP includes a first reservoir 200, a DP magnet 70, a cannula 200, and an adhesive base 190. When the trigger 120 is pushed, the inserter rotating nut 360 and the inserter thread 361 rotate around the pivoting rod 350 by the inserter spring 370. When the rotating thread 361 rotates, the hammer linear thread 381 moves linearly downward (in the direction of the thick dashed line), and as a result, the hammer 380 and the hammer pusher 383 move in the same direction. When the cannula pusher 383 moves downward, the cannula 200 moves in the direction of the dashed line.

[0107] Figures 41A - B show cross-sectional views of the inserter 300 and the patch pump 1 before (Figure 41A) and after (Figure 41B) filling the first reservoir 120 according to some embodiments. The inserter 300 includes a trigger 320, a viewing window 390, an inserter spring 370, and an inserter hammer 380. The patch pump 1 includes a first reservoir 120, a plunger 121 of the first reservoir, a cannula 200, an adhesive base 190, and a liner 197. During filling of the first reservoir, the plunger 121 of the second reservoir moves in the direction of the thick dashed arrow (Figure 41A) by insulin. When the first reservoir 120 is filled to its maximum capacity (Figure 41B), the plunger 121 of the first reservoir is positioned at its proximal end.

[0108] Figures 42A - B show a plan sectional view of the release mechanism 340 before (Figure 42A) and after (Figure 42B) activation of the inserter 300 according to some embodiments. By rotation of the dispenser 363 (in the counterclockwise direction) (Figure 42A), the lever 3111 moves horizontally (in the direction of the thick dashed arrow), and by the lever 3111, the DP holder 311 moves in the same horizontal direction. As a result (Figure 42B), the DP adhesive base 190 disengages from the inserter.

[0109] Figures 43A - E show spatial diagrams of the handling of inserter 300 according to some embodiments. Figure 43A shows the insertion into the inserter notch 312 of RP10 and the connection (partially shown) with the DP100 of RP10. Figure 43B shows the patch pump 1 (partially shown) within the inserter 300, where RP10 connects to the DP100 here. The liner 197 wraps around the upper and bottom sides of the adhesive base 190. Figure 43C shows the filling of the first reservoir. The patch pump (not shown) is installed on the bottom side of the inserter 300. Insulin is injected through the filling hole 181 with the syringe 500 and a hypodermic needle (not shown). Figure 43D shows the inserter 300 and the patch pump 1 after removing the liner 197 from the adhesive base 190. Figure 43E shows the inserter 300 after separation from the patch pump 1. The adhesive base 190 adheres to the patient's skin here, and the inserter 300 is disposed of.

[0110] Figures 44A - D show cross - sectional views (from the perspective of the viewing window) of the inserter 300 during priming and cannula insertion, according to some embodiments. Figure 44A shows the inserter 300 including the trigger 320 and the viewing window 390. The DP is positioned within the inserter 300, and the cannula 200 and the cannula cap 50 can be seen through the viewing window 390. After the insertion of the RP into the inserter (Figure 42), the patch pump is ready for priming. Priming is automatically performed by a command received by the patch pump from the controller. Figure 44B shows an enlarged view (thin dashed - line arrows) of the viewing window 390 during priming. The cannula 200, the cannula cap 50, and the cannula opening 118 can be seen through the viewing window 390 of the inserter. During priming, the inserter 300 and the viewing window 190 are held in an upright position (dashed - line arrows). When it can be seen that insulin continuously (e.g., without air bubbles) appears (drips) from the cannula opening 118, priming is complete, the patch pump can adhere to the skin, and the cannula 200 can be inserted. Figure 44C shows the inserter 300 during the start of the cannula insertion process. The trigger 320 is pushed downward in the direction of the thick dashed - line arrow, and the cannula 200 is moved in the same direction by the hammer cannula pusher 383. Figure 44D shows the inserter and the patch pump (not shown) at the end of the cannula 200 insertion process. The trigger 320 is pushed in the direction of the thick dashed - line arrow. After the completion of the linear movement in the same direction, the hammer straight thread 381 can be seen within the viewing window 190, and the cannula protrudes from the bottom side (not shown) of the adhesive base after it has completely moved in the same direction.

[0111] Figures 45A - B show partial perspective cross - sectional views (from the perspective of the viewing window) of the inserter 300 and the patch pump 1 before (Figure 45A) and after (Figure 45B) the insertion of the cannula 200 according to some embodiments. The inserter 300 includes a trigger 320, a viewing window 390, an inserter spring 370, a hammer straight thread 381, and a hammer cannula pusher 383. The patch pump 1 includes a first reservoir 120, a dispenser 130, a cannula 200, and a cannula cap 50. Figure 45A shows the inserter 300 during the activation of the cannula insertion process. The trigger 320 is pushed downward in the direction of the thick dashed arrow, and the cannula 200 is moved in the same direction by the hammer cannula pusher 383. Figure 45B shows the inserter 300 and the patch pump 1 at the end of the cannula 200 insertion process. The trigger 320 is pushed in the direction of the thick dashed arrow, and the hammer straight thread 381 becomes visible in the viewing window 190 after the completion of the linear movement in the same direction. The cannula protrudes from the bottom side (not shown) of the adhesion base after it has moved completely in the same direction.

[0112] Figures 46-53 show a reversible engagement mechanism between the RP male screw and the DP syringe plunger according to some embodiments. The engagement mechanism provides a secure connection during patch pump operation and allows for engagement and disengagement during RP-DP separation. For example, FIGS. 46A-C show an exemplary embodiment of the engagement mechanism between the male screw 44 and the syringe plunger 131. FIG. 46A shows the male screw 44 including the male screw tip 441 and the male screw protrusion 443. The syringe 130 is rigidly connected to the slide needle 140 and can move linearly within a sleeve (not shown) and the sleeve cover 173. The sleeve cover 173 has a protrusion 174. The syringe plunger 131 can move linearly within the syringe 130. The syringe plunger 130 includes a piston 132, a gasket 134, and a scraper spring 175. During RP-DP connection (in the direction of the thick dashed arrow), the male screw tip 441 and the male screw protrusion 443 reversibly engage with the spring scraper 175. FIG. 46B shows the engaged male screw 44 and the spring scraper 175. The syringe plunger 131 is positioned at the most proximal location within the syringe 130, and the scraper petal portion 177 (enlarged view in FIG. 47) touches the sleeve cover protrusion 174. When the male screw 44 moves linearly in the direction (X) of the thick dashed arrow, the plunger 131 moves in the same direction. When the male screw 44 moves linearly in the direction (Y) of the thick dashed arrow, the spring scraper petal portion 177 is pushed into the sleeve cover protrusion 174, resulting in the expansion of the spring scraper 175, the disengagement of the male screw protrusion 443, and the ability of the male screw 44 (and the entire RP) to disengage from the syringe plunger 31 (and the entire DP). FIG. 46C shows the male screw 44 engaged with the spring scraper 175, with the male screw tip 441 and the male screw protrusion 443 positioned within the spring scraper groove 179 (shown in FIG. 47), and the syringe plunger 131 moving in the direction of the thick dashed arrow to the most distal position within the syringe 130 (at the end of the syringe discharge phase, FIG. 55).

[0113] Figures 47A - C show an enlarged spatial view of the spring scraper 175 and the parent screw 44 according to some embodiments. Figure 47A (side view) and Figure 47B (top view) show the spring scraper 175. The spring scraper includes a scraper rib 176, a scraper petal part 177, and a scraper groove 179. Figure 47C shows the parent screw 44 including a parent screw tip 441 and a parent screw protrusion 443. When the parent screw 44 engages with the spring scraper 175, the parent screw tip 441 and the parent screw protrusion 443 are present within the spring scraper groove 179.

[0114] Figures 48A - B show longitudinal sectional views of the parent screw 44 and the syringe plunger 131 before (Figure 48A) and after (Figure 48B) engagement according to some embodiments. The parent screw 44 includes a parent screw tip 441 and a parent screw protrusion 443. The syringe plunger 131 includes a gasket 134, a rib 176 of the scraper spring, and a petal part 177 of the scraper spring. Figure 48A shows the parent screw 44 and the syringe plunger 131 before engagement. The parent screw 44 moves in the direction of the thick dashed arrow and is present within the groove 179 of the scraper spring. Figure 48B shows the parent screw 44 engaged with the scraper spring 175. The scraper spring 175 includes a rib 176 of the scraper spring and a petal part 177 of the scraper spring. The parent screw tip and the parent screw protrusion (not shown) are seated within the groove 179 of the scraper spring.

[0115] Figures 49A - C show a spatial view (Figures 49A - B) and a sectional view (Figure 49C) of the insertion engagement mechanism according to some embodiments. The driving screw 644 has a tip 645 having a T - shaped configuration (Figure 50). The sleeve cover 600 includes four fitting teeth 601, and the syringe plunger 610 includes four fitting teeth 611. When the plunger 610 is positioned at the most proximal position, the fitting teeth 611 of the syringe plunger and the fitting teeth 601 of the sleeve cover engage, the syringe plunger 611 rotates, and the driving screw tip 645 disengages from the syringe plunger 610.

[0116] Figures 50A - F show perspective views of a syringe plunger 610 (Figs. 50A - B), a sleeve cover 600 (Fig. 50C), and a driving screw tip 645 (Figs. 50D - F) according to some embodiments. The plunger 610 includes four fitting teeth 611, and the sleeve cover 600 includes four fitting teeth 601. In some embodiments, the plunger and / or the sleeve cover may include fewer or more than four fitting teeth. When the fitting teeth 601 engage with the fitting teeth 611, the syringe plunger 610 rotates and the driving screw tip 645 disengages from the syringe plunger 610.

[0117] Figures 51A - D show a cross - sectional view (Fig. 51A), a perspective cross - sectional view (Fig. 51B), and perspective views (Figs. 51C - D) of a coupling engagement mechanism according to some embodiments. The driving screw 744 includes a tip 745 having a gun shape. The syringe plunger 731 includes a circular notch 746. The driving screw tip 744 engages firmly with the notch 746 of the syringe plunger due to non - collinearity (coupling phenomenon). When the plunger 731 is placed at the most proximal position within the syringe 730, the circular notch 746 of the syringe plunger and the driving screw tip 745 are aligned on the same line and can be disengaged.

[0118] Figure 52 shows a cross - sectional view of an O - ring engagement mechanism according to some embodiments. The driving screw 844 includes a raised tip 845. The syringe plunger 831 includes an O - ring 846. When the plunger 831 is placed at the most proximal position within a syringe (not shown), as the driving screw moves further in the direction of the thick dashed arrow, the raised tip 845 compresses the O - ring 846 and the driving screw 844 disengages from the syringe plunger 831.

[0119] Figures 53A - B show a cross - sectional view (Figure 53A) and a spatial view (Figure 53B) of a pot magnet engagement mechanism according to some embodiments. The driving screw 944 includes a bowl - shaped tip 948 and a magnet / iron plate 945 connected to the bowl - shaped tip 948. The syringe plunger 931 includes a magnet / iron plate 946. When the driving screw moves linearly in the direction of the plunger 931 and in the opposite direction of the plunger 931 respectively, the bowl - shaped tip 948 and the syringe plunger 931 can engage (thick dashed arrow X) or disengage (thick dashed arrow Y).

[0120] Figures 54A - E show a cross - sectional view (Figure 54A) and spatial views (Figures 54B - E) of a washer engagement mechanism such as a relief groove according to some embodiments. The driving screw 954 includes a tip 955 shaped like a gun. The syringe plunger 951 includes a conical cavity 957. A conical scaffold 956 having an opening 958 occupies the cavity 957. When the driving screw 954 engages with the syringe plunger 951, the driving screw tip 955 is placed within the opening 958, and the tip 955 firmly engages with the scaffold 956. When the plunger 951 is placed at the most proximal position within the syringe 960, the scaffold 956 moves within the cavity 957 in the direction of the thick dashed arrow, and the driving screw tip 955 can disengage from the scaffold 957.

[0121] Figures 55 - 58 show illustrations of a patch pump operation including a pump mechanism (syringe filling phase in Figure 55 and syringe discharging phase in Figure 56), and priming of the patch pump (Figure 57), as well as reservoir filling (Figure 58) according to some embodiments. The pump mechanism of the patch pump includes an operating cycle consisting of two operating phases: a syringe filling phase and a syringe discharging phase. During the syringe filling phase, insulin is delivered from the first reservoir to the syringe. During the syringe discharging phase, insulin is delivered from the syringe to the outlet and from the outlet through the cannula to the patient. The priming cycle of the patch pump includes two operating phases: a syringe filling phase and a syringe discharging phase. During the syringe discharging phase, insulin is delivered from the syringe to the outlet, from the outlet to the cannula opening, and from the cannula opening into the air.

[0122] FIG. 55 shows an illustration of a pump mechanism during a medicator filling phase, according to some embodiments. The pump mechanism includes a first reservoir 120, a second reservoir (medicator) 130, a two-chamber valve mechanism (the “valve mechanism”) 160, a first conduit 150, a second conduit 151, an outlet 115, and a cannula 200. A filling conduit 152 is hydraulically connected to the first conduit 150. The first reservoir 120 has a proximal end 1221, a distal end 1222, and a first conduit - first reservoir passage 1501. The plunger 121 of the first reservoir can move passively in the direction of the thick arrow (X). The medicator 130 has a proximal end 1331 and a distal end 1332. The medicator plunger 131 can move in the direction of the thick arrow (Y) by the parent screw 44. The movement of the medicator in the direction of the thick arrow (Y) is restricted by the medicator proximal stopper 147 (the proximal end of the sleeve 1771). The movement of the medicator 130 in the opposite direction during the medicator discharge phase is restricted by the medicator distal stopper 146 (the distal end of the sleeve 1772) (FIG. 56). The medicator 130 is firmly connected to the slide needle 140, and the cavity 1333 of the medicator is in hydraulic communication with the slide needle 140. The slide needle has a proximal end 141, a distal end (sharp tip) 142, and an opening 144 (one or more openings). The valve mechanism 160 includes an injection chamber 161, a discharge chamber 162, a rear seal 164, a front seal 166, a first conduit - injection chamber passage 1502, and a discharge chamber - second conduit passage 1511. The outlet 115 includes a top seal 113 and a bottom seal 114. During the medicator filling phase, the parent screw 44 and the medicator plunger move in the direction of the thick arrow Y. At the start of the movement of the medicator plunger 131, the medicator 130 moves in the direction of the thick dashed arrow (Z) until it reaches the proximal stopper 147 (due to the frictional force between the medicator 130 and the medicator plunger 131). Following the movement of the medicator 130, the slide needle 140 moves in the same direction, and the slide needle opening 144 is positioned within the injection chamber 161. At this point, as the plunger 131 moves further in the direction of the thick arrow (Y), insulin moves in the direction of the thin dashed arrow, and the plunger 121 of the first reservoir moves in the direction of the thick arrow (X).Insulin is delivered from the first reservoir 120 through the first conduit 150, the injection chamber 161, the slide needle opening 144, and the slide needle 140 into the dispenser 130.

[0123] FIG. 56 shows an illustration of the pump mechanism during the dispenser discharge phase according to some embodiments (the names of the components are provided in the above description with respect to FIG. 55). During the dispenser discharge phase, the male screw 44 and the dispenser plunger 131 move in the direction of the thick arrow Y. At the start of the movement of the dispenser plunger 131, the dispenser 130 moves in the direction of the thick dashed arrow (Z) until it reaches the distal stopper 146. Following the movement of the dispenser 130, the slide needle 140 moves in the same direction and the slide needle opening 144 is positioned into the discharge chamber 162. At this point, as the plunger 131 further moves in the direction of the thick arrow (Y), insulin moves in the direction of the thin dashed arrow. Insulin is delivered from the dispenser 130 through the slide needle 140, the slide needle opening 144, the second conduit 151, the outlet 115, and the cannula 200 into the subcutaneous tissue of the patient.

[0124] Figure 57 shows an illustration of the pump mechanism during priming of a patch pump, according to some embodiments (the names of the components are provided in the above description regarding Figure 55). The cannula 200 is not inserted into the patient's body, the cannula tip 117 is seated within the well 115, and the cannula cap 50 and the cannula opening 118 are positioned above the DP housing (110, dashed rectangle). Following manual filling of the reservoir (Figure 58), upon receiving a command from the controller, the patch pump (and the inserter, Figure 44) is guided through an automatic priming process (air purge) while being held in an upright position. The priming process includes a priming cycle with two phases, a syringe filling phase and a syringe discharging phase, that are the same as the pump operation phases (Figures 55 and 56). The syringe filling phase of the priming process is the same as the syringe filling phase of the pump operation cycle (Figure 55). During the syringe discharging phase of the priming process, the parent screw 44 and the syringe plunger 131 move in the direction of the thick arrow Y. At the start of the movement of the syringe plunger 131, the syringe 130 moves in the direction of the thick dashed arrow (Z) until it reaches the distal stopper 146. Following the movement of the syringe 130, the slide needle 140 moves in the same direction and the slide needle opening 144 is positioned within the discharge chamber 162. At this point, as the plunger 131 moves further in the direction of the thick arrow (Y), insulin moves in the direction of the thin dashed arrow. Insulin is delivered into the air through the syringe 130, the slide needle 140, the slide needle opening 144, the second conduit 151, the outlet 115, and the cannula opening 118. If no insulin is observed (dripping emerging from the opening 118 in Figure 44) after one priming cycle (syringe filling phase and syringe discharging phase), continuous priming cycles continue at the discretion of the patient until insulin dripping is visible.

[0125] FIG. 58 shows an illustration of the pump mechanism during patch pump filling (component names are provided in the above description regarding FIG. 55). The cannula 200 is not inserted into the patient's body, the cannula tip 117 is seated within the well 115, and the cannula cap 50 and the cannula opening 118 are seated above the DP housing (110, dashed rectangle). The syringe plunger 131 is seated at the most distal position 1332, and the slide needle opening 144 is seated within the discharge chamber 162. Insulin is injected with the filling syringe 500 through the needle 510 into the filling conduit 152 and through the first conduit 150 into the first reservoir 120. During filling, the plunger 121 of the first reservoir moves in the direction of the thick arrow. The first reservoir 120 can be filled to any desired volume (FIGS. 71 - 73) up to its maximum capacity.

[0126] FIGS. 59 - 64 show the disposable components of the pump mechanism and the operating cycle of the pump mechanism according to some embodiments. For example, in some embodiments, FIG. 59 shows a plan cross - sectional view of some of the DP100 components and the disposable components of the pump mechanism. The DP100 components include the first reservoir 120, the syringe 130, the valve mechanism 160, the second conduit 151, the delivery conduit 153, and the filling port 180. The syringe plunger 131 and the slide needle 140 are seated at the most distal positions (at the end of the syringe discharge phase).

[0127] FIG. 60 shows an enlarged cross-sectional view of a disposable component of a pump mechanism, according to some embodiments. The pump mechanism includes a syringe 130, a syringe plunger 131, a sleeve 171, a sleeve cover 173, and a valve mechanism 160. The syringe 130 includes a syringe wall 1334 and a syringe cavity 1333. The syringe 130 is rigidly connected to a slide needle 140, and the syringe cavity 1333 is in hydraulic communication with the slide needle 140. The syringe plunger 131 includes a syringe piston 132, a syringe gasket 134, and a scraper spring 175. The sleeve 171 and the sleeve cover 173 form a cylinder having a proximal end 1771 and a distal end 1772. The sleeve cover has a protrusion 174. The valve mechanism 160 includes an injection chamber 161, an exhaust chamber 162, a front spacer 163, a rear seal 164, a rear spacer 165, and a front seal 166. The exhaust chamber 162 is in hydraulic communication with a second conduit 151. The RP-DP O-ring 170 passes through the sleeve 171 and provides a seal for the RP seal compartment after RP-DP connection (FIGS. 11 and 24). The syringe 130 can move linearly within the sleeve 171, and the syringe plunger 131 can move linearly within the syringe 130. When the syringe plunger 131 is in its most proximal position, the spring scraper 175 engages the sleeve cover protrusion 174 (FIGS. 46-48).

[0128] Figures 61A - C and 62A - C show cross - sectional views of the syringe 130 and the valve mechanism 160 in the syringe filling phase (Figures 61A - C) and the syringe discharging phase (Figures 61A - C) according to some embodiments. Figure 61A shows the syringe 130, the syringe plunger 131, the sleeve 171, and the valve mechanism 160. The syringe 130 has a proximal end 1331 and a distal end 1332. The sleeve 171 has a proximal end 1771 and a distal end 1772. At the start of the syringe filling phase, the syringe 130 is positioned at the most distal position within the sleeve 171 (as the thin double - headed arrow moves, 1332 and 1772 contact and 1331 and 1771 separate), the syringe plunger 131 is positioned at the most distal position within the sleeve 171, and the slide needle opening 144 is positioned within the discharge chamber 162. At this stage, the syringe 130 moves in the direction of the dashed arrow. Figure 61B shows the syringe 130 after moving within the sleeve (as the thin double - headed arrow shows, 1332 is positioned away from 1772 and 1331 and 1771 contact), and the slide needle opening 144 is positioned within the injection chamber 161. In this phase, as the syringe plunger 131 further moves in the direction of the thick dashed arrow, the syringe plunger 131 moves linearly within the syringe 130. Figure 61C shows the syringe plunger 131 after moving in the direction of the thick dashed arrow within the syringe 130. The syringe plunger 131 is positioned away from the distal end 1332 of the syringe (thin double - headed arrow). As the syringe plunger 131 moves within the syringe 130, insulin moves in the direction of the thick dashed arrow, and as a result, the syringe 130 is filled.

[0129] Figure 62A shows the syringe 130 and the syringe plunger 131 at the start of the syringe discharge phase. The syringe 130 is positioned at the most proximal position within the sleeve 171 (as it moves as indicated by the thin double-headed arrow, 1331 and 1771 come into contact and 1332 and 1772 separate), the syringe plunger 131 is positioned at the most proximal position within the syringe 130, and the slide needle opening 144 is positioned within the injection chamber 161. At this stage, the syringe 130 moves in the direction of the dashed arrow. Figure 62B shows the syringe 130 after moving in the direction of the thick dashed arrow within the sleeve 171. The proximal end 1331 of the syringe is positioned away from the proximal end 1771 of the sleeve (thin double-headed arrow), the distal end 1332 of the syringe and the distal end 1772 of the sleeve are in contact, and the slide needle opening 144 is positioned within the discharge chamber 162. Figure 62C shows the syringe plunger 131 after moving in the direction of the thick dashed arrow within the syringe 130. The syringe plunger 131 is positioned away from the proximal end 1331 of the syringe. As the syringe plunger 131 moves within the syringe 130, insulin moves in the direction of the thick dashed arrow, resulting in the syringe 130 being emptied.

[0130] Figures 63A - B show enlarged cross-sectional views of the valve mechanism 160 during the syringe filling phase (Figure 63A) and the syringe discharge phase (Figure 63B) according to some embodiments. The valve mechanism 160 includes an injection chamber 161, a discharge chamber 162, a front spacer 163, a rear seal 164, a rear spacer 165, and a front seal 166. During the syringe filling phase (Figure 63A), the distal end of the syringe 130 is away from the distal end of the sleeve 171 (thick dashed double arrow), and the slide needle opening 144 is positioned within the injection chamber 161. During the syringe discharge phase (Figure 63B), the distal end of the syringe 130 is in contact with the distal end of the sleeve 171, and the slide needle opening 144 is positioned within the discharge chamber 162.

[0131] Figures 64A - B show a cross - sectional view (Figure 64A) and a spatial view (Figure 64B) of the slide needle 140 according to some embodiments. The slide needle includes a proximal end 141, a distal end 142, and an opening 144. The proximal end is in hydraulic communication with the cavity of the dispenser. The distal end is hidden and has a sharp tip. In some embodiments, there are two slide needle openings. In some embodiments, one or more openings are provided.

[0132] Figures 65 - 67 show hardware components and operating modes of the hardware according to some embodiments. For example, in some embodiments, Figure 65 shows a spatial view of the hardware components of the RP (the RP cover 25 in Figure 7 is removed). The hardware includes a PCB 61 (folded) and a battery 80. The PCB 61 comprises various electronic components (i.e., microprocessor, transceiver, sensors, etc.). It shows a part of the RP components including the motor 42, the lead screw 44, and the sockets for the reservoir sensors 641 and 642.

[0133] Figure 66 shows a hardware state machine according to some embodiments. The processor issues commands to the drive mechanism, receives inputs from sensors (i.e., encoder sensors), and accordingly adjusts the operation of the drive mechanism. The processor receives inputs from a timer (i.e., RTC), memory, and RF transceiver and delivers outputs for alarms / warnings. There is bidirectional communication between the processor, the memory, and the transceiver, and between the sensors and the drive mechanism.

[0134] FIG. 67 shows a hardware block diagram according to some embodiments. The processor receives inputs from sensors (encoder sensor, dispenser sensor, and reservoir sensor) and controls a motor driver, power management, watchdog, buzzer driver, and BLE antenna. The motor driver operates a motor (i.e., a stepper motor) and an encoder. The processor receives an input from the encoder and adjusts the operation of the motor accordingly. A battery (e.g., a lithium ion) is charged by an external power source through a charging contact.

[0135] FIGS. 68 - 70 show the components and operating modes of the dispenser sensor 63 according to some embodiments. The dispenser sensor 63 detects the relative movement between the dispenser 130 and the sleeve 171, the position of the dispenser 130 at the end of the dispenser filling phase and the dispenser discharging phase, and the RP - DP connection and separation. During the dispenser discharging phase (FIG. 56), if there is relative movement between the dispenser 130 and the sleeve 171 instead of relative movement between the dispenser plunger 131 and the dispenser 130, occlusion may be detected by the dispenser sensor 63 during motor operation.

[0136] Figures 68A - C illustrate the operating modes of the dispenser sensor 63 according to some embodiments. The dispenser sensor 63 consists of a reflective micro - photodetector 632 (the "detector") and a dispenser sticker 145 that adheres to the dispenser 130. The input (voltage) from the detector 632 is processed by a microprocessor that controls the operation of the motor (i.e., the direction of rotation) or provides warnings and alerts. The dispenser sticker 145 contains a barcode. In some embodiments, the barcode includes two zones of black and white. The barcode can consist of bars of various widths, any protruding structures, or any other configuration detectable by the detector 632. Figures 68A and 68B show the operation of the dispenser sensor during the pump operation cycle (dispenser filling phase and dispenser discharging phase). When the dispenser 130 moves back and forth in the direction of the thick dashed arrow, the dispenser sticker 145 moves in the same direction, and the micro - photodetector 632 aligns with the white (Figure 68A) or black (Figure 68B) barcode accordingly. The change in the light reflectivity (thin dashed arrow) is converted by the detector 632 into a change in current and voltage. During the movement of the dispenser 130 (transition from black to white), the current gradually increases (gradual increase in light reflectivity). During the movement of the dispenser 130 (transition from white to black), the current gradually decreases (gradual decrease in light reflectivity). When the movement of the dispenser 130 stops (in both directions), the current (and voltage) remains constant and the processor 62 interprets that there is no movement of the dispenser 130. When the movement of the dispenser 130 stops (in both directions), further movement of the dispenser plunger (Figures 55 - 56) causes insulin to move into (dispenser filling phase) or out of (dispenser discharging phase) the dispenser. During the dispenser discharging phase, the exact amount of insulin moved (insulin delivery volume, i.e., insulin units) is derived from the calculation of the number of revolutions of the gear (encoder sensor of Figures 9 - 10) that begins immediately after the dispenser stops moving and the dispenser plunger starts moving within the dispenser (Figures 55 - 56). Figure 68C shows the operation of the dispenser sensor 63 during RP - DP separation. RP10 includes the micro - photodetector 632 and the processor 62. DP100 includes the dispenser 130 and the dispenser sticker 145.When RP10 and DP100 separate (move in the direction of the thick dashed arrow) and the micro-photodetector 632 does not receive light reflection (thin dashed arrow), the input is received by the processor and interpreted as RP-DP separation. During RP-DP connection (not shown), it is detected that the detector 632 is aligned with the barcode of the sticker 145 and is interpreted as an RP-DP connection.

[0137] FIG. 69 shows a cross-sectional view of a medicator sensor 63 (dashed rectangle) and the main components of RP and DP, according to some embodiments. RP10 includes a parent screw 44, a rotary nut 435, and a micro-photodetector 632. DP100 includes a medicator 130, a medicator sticker 145, a sleeve 171, a valve mechanism 160, and a slide needle 140. The medicator sensor 63 (dashed rectangle) consists of a micro-photodetector 632 and a medicator sticker 145.

[0138] Figures 70A - E show cross - sectional views of the dispenser sensor 63 during pump operation and during RP - DP separation, according to some embodiments. For example, in some embodiments, Fig. 70A (dispenser discharge phase) and Fig. 70B (dispenser filling phase) show the dispenser sensor 63 (dashed rectangle), the dispenser 130, the sleeve 171, and the parent screw 44. The dispenser sensor 63 consists of a micro - photodetector 632 and a dispenser sticker 145. Movements of the dispenser 130 and the dispenser sticker 145 in the forward and reverse directions (thick dashed arrows) are detected by the micro - photodetector 632, and accordingly, the relative position of the dispenser 130 (relative to the sleeve 171 and the RP 10) is accurately defined by the detector 632 and interpreted by the processor as a result. Figs. 70C - E show successive stages of RP - DP separation, with the RP moving in the direction of the thick dashed arrow. Fig. 70C shows the first stage of inadvertent separation of RP - DP, where the dispenser plunger 131 is in an intermediate position within the dispenser 130 and the detector 632 is aligned with the dispenser sticker 145. Fig. 70D shows the next successive stage of RP - DP separation, where the dispenser plunger 131 moves further in the direction of RP movement (thick dashed arrow) and the detector 632 is not aligned with the dispenser sticker 145. Fig. 70E shows the completion of RP - DP separation, where the dispenser plunger 131 contacts the sleeve cover 173, the parent screw 44 disengages from the dispenser plunger 131, and the detector 632 is not aligned with the dispenser sticker 145. During RP - DP connection (movement of the RP in the opposite direction), the parent screw 44 engages with the dispenser plunger 131, the detector 632 is aligned with the dispenser sticker 145, reflected light is detected by the detector 632, and the output (voltage) of the detector is interpreted by the processor as the connection between the RP and the DP.

[0139] Figure 71 shows an illustration of the components of the reservoir sensor 64, the location of the components of the reservoir sensor 64, and the operating modes of the reservoir sensor 64, according to some embodiments. Figure 71 shows a section of the RP10 that includes the venting compartment 22 and the sealing compartment 21 (Figure 11). The sealing compartment 21 includes the PCB 61, which includes the processor 62, Hall sensor 1 of 651, and Hall sensor 2 of 652. Hall sensor 1 of 651 is seated within reservoir sensor socket 1 of 641, and Hall sensor 2 of 652 is seated within reservoir sensor socket 2 of 642 (Figure 65). The first reservoir 120 and the plunger 121 of the first reservoir are part of the DP100. When the RP10 and the DP100 are connected, the first reservoir 120 (part of the DP100) is seated within the venting compartment 22 (Figure 11) of the RP10. In some embodiments, the reservoir sensor 64 includes two Hall sensors, an axial pole magnet 65, and Hall sensor 1 of 651 and Hall sensor 2 of 652. In some embodiments, the magnet can be radial, rectangular, or circular. The axial pole magnet 65 is firmly attached to the plunger 121 of the first reservoir, which is seated within the first reservoir 120. Hall sensor 1 of 651 and Hall sensor 2 of 652 are seated extremely close to the first reservoir 120. A Hall sensor is a transducer that changes its output voltage in response to a magnetic field. Hall sensors 1 and 2 of 651 and 652 operate as analog transducers and directly return a voltage. Given a known magnetic field, the distance from the axial pole magnet 65 can be determined. Two or more sensors can be used to estimate the relative position of the axial pole magnet 65. The outputs of both Hall sensors 651 and 652 are received and processed by the processor 62 and transmitted to the controller. The axial pole magnet 65 moves within the first reservoir 120 (along the plunger 121 of the first reservoir) during filling of the first reservoir 120 and during pump operation (moving back and forth in the directions of the thick dashed arrows X and Y, respectively).The reservoir sensor 64 can provide one or more of the following data points: 1 - the exact or substantially exact amount of insulin in the first reservoir 120; 2 - the volume of insulin exceeding a minimum threshold (e.g., about 50 units, about 40 units, about 30 units, including values in between) such that the plunger 121 of the first reservoir moves in the direction of the thick dashed arrow X beyond a predetermined point; 3 - the data point that the pump mechanism is functioning properly, i.e., during the dosing filling phase, the plunger 121 of the first reservoir moves in the direction of the thick dashed arrow Y; 4 - the remaining amount of insulin left in the first reservoir 120; and 5 - the data point that the volume of insulin falls below the minimum threshold, issuing a low insulin level warning. In some embodiments, two, three, four, five or more hall sensors are provided.

[0140] FIG. 72 shows a spatial diagram of some components of the patch pump 1 and the positions of the reservoir sensor sockets 641 and 642, according to some embodiments. The patch pump 1 includes an RP including an RP base 24, a bottom RP groove 231, a reservoir sensor socket 641 of the first, and a reservoir sensor socket 642 of the second. The DP includes a DP housing 110, a first reservoir 120, a dispenser 130, and an adhesive base 190. After RP-DP connection, the reservoir 120 is in very close proximity to the reservoir sensor sockets 641 and 642.

[0141] FIG. 73 shows an exemplary output graph of the reservoir hall sensors 651 and 652, according to some embodiments. The output of the reservoir hall sensors was measured while the plunger 121 of the first reservoir and the axial pole magnet 65 were moving in the direction of the thick dashed double arrow within the first reservoir 120. Curves 6511 and 6522 show the outputs of the reservoir hall sensors 651 and 652 relative to the reference value line (X) in some embodiments. The exact location (in millimeters from the zero point) of the plunger 121 of the first reservoir within the first reservoir 120 can be determined by subtracting the measurements (i.e., current or voltage) of both the reservoir hall sensors 651 and 652.

[0142] Figures 74 - 83 show the components and operating modes of the bubble prevention means according to some embodiments. Bubbles can enter into the first reservoir during filling (when air is not properly purged from the filling syringe) or during pump operation. During the dosing device filling phase, the dosing device plunger moves (Figure 55), creating a negative pressure throughout the fluid manifold (dosing device, conduit, and first reservoir), and according to the negative pressure gradient, fluid (e.g., insulin) moves from the first reservoir to the dosing device. The pressure gradient (relative to the atmosphere) between the atmosphere and the relative negative pressure within the first reservoir can push the movement of air through the plunger gasket of the first reservoir into the first reservoir cavity, potentially forming bubbles within the fluid of the first reservoir. The bubble prevention means includes passive prevention means (Figures 74 - 75), which are barriers against the entry of air into the first reservoir through the plunger gasket of the first reservoir, and active bubble prevention means (Figures 76 - 83) that avoid the pressure gradient between the atmosphere and the first reservoir cavity. Pressure equilibrium or a reverse pressure gradient (pressure in the first reservoir is higher than the atmosphere) can be achieved by actively increasing the pressure in the first reservoir to atmospheric pressure or above atmospheric pressure.

[0143] FIG. 74 shows a cross-sectional view and the operating principle of a component of a passive bubble prevention means, which is the oil 128 between the plunger gaskets 124 and 125 of the first reservoir, according to some embodiments. The oil 128 between the gaskets forms a barrier against air entry by sealing and closing all potential folds of the first reservoir wall 126, as well as potential deformations and protrusions (i.e., dividing lines) of the gaskets 124 and 125. The oil 128 can be introduced between the gaskets 124 and 125 by the following options: 1 - the assembly of the gaskets 124 and 125 over the plunger 131 of the first reservoir within a container filled with oil; 2 - the injection of oil through an oil-filled diaphragm 1281 and through an oil-filled channel 1282; 3 - the provision of a negative pressure before oil filling. The injected oil 128 is delivered in the direction of the thin dashed arrow and introduced into the space between the gaskets 124 and 125. The oil 128 between the gaskets remains in place during the filling of the first reservoir (in the direction of the thick dashed arrow X) and during the pumping operation (in the direction of the thick dashed arrow Y). In addition to sealing, the oil 128 facilitates the smooth movement of the plunger 121 of the first reservoir, as well as the gaskets 124 and 125.

[0144] FIG. 75 shows a cross-sectional view and the principle of operation of components of another passive air bubble defense means, which is the drug (e.g., insulin) 129 between the plunger gaskets 124 and 125 of the first reservoir, according to some embodiments. The air bubble defense barrier is the drug 129 delivered by the patch pump, i.e., insulin or any other therapeutic fluid. FIG. 75 shows the first reservoir 120, the first reservoir wall 126, the plunger 121 of the first reservoir, the gaskets 124 and 125 of the first reservoir, the first reservoir filling cavity 1295, the first conduit 150, the top membrane 1291, the air cavity 1292, the fluid resistor 1293, the one-way gate 1294, and the insulin 129. The first reservoir filling cavity 1295 has a semi-conical shape, or any other cavity shape that allows the drug to pass from 150 to 1293, and is formed by rubbing against the first reservoir wall 126 at the most distal end 1222. The first reservoir filling cavity 1295 is in hydraulic communication with the first conduit 150. During filling of the first reservoir 120, the insulin 129 is delivered through the first conduit 150 into the first reservoir filling cavity 1295 and occupies the space between the gaskets 124 and 125. The air trapped between the gaskets before filling is pushed through the fluid resistor 1293 and the one-way gate 1294 into the air cavity 1292 and from the cavity 1292 through the top membrane 1291 to the atmosphere. The fluid restrictor 1293 is a microchannel that provides a passage for air and blocks or restricts the fluid passage. The one-way gate 1294 can be made of any semi-permeable material (e.g., Gore-tex® material) or any other elastomer that is pushed against the pores (i.e., duck valve) to provide additional defense against the fluid passage. The top membrane 1291 serves as a second line of defense in case the one-way gate 1294 fails. When the first reservoir filling cavity 1295 and the space between the gaskets 124 and 125 are completely occupied by the insulin 129, further injection of the insulin 129 into the first reservoir causes the plunger 121 of the first reservoir to move in the direction of the thick dashed arrow.When the plunger 121 of the first reservoir moves in the direction of the thick dashed arrow X (reservoir filling), the first gasket 124 adheres to the reservoir wall 126, providing a double seal (by both gaskets). The double seal is provided along the entire length that the plunger 121 of the first reservoir moves within the first reservoir 120 in the direction of the dashed arrow X (reservoir filling) and in the direction of the dashed arrow Y (pump operation).

[0145] Figures 76 - 83 show the components and operating modes of the active bubble prevention means according to some embodiments. At the end of the medicator filling phase, the negative pressure in the manifold (reservoir, conduit, and chamber) rises above atmospheric pressure (P+) by returning a defined fluid volume into the manifold. This can be achieved by locking the medicator 130 at the beginning of the medicator discharge phase, avoiding relative movement of the medicator (with respect to the sleeve), and movement of the slide needle opening from the injection chamber to the discharge chamber (Figs. 55 - 56). When the medicator 130 is locked, further movement of the medicator plunger 131 causes insulin to move in the direction of the first reservoir 120 (backflow direction). The amount of insulin entering the first reservoir 120 increases the pressure in the first reservoir 120 above atmospheric pressure (P+). The amount of pressure increase in the first reservoir 120 depends on the predetermined amount returned into the first reservoir and the amount of air bubbles trapped within the reservoir.

[0146] Figures 76A - B, 77A - B, 78A - B, and 79 show illustrations of the dosing lock mechanism during various phases of the operating cycle of a pump mechanism, according to some embodiments. The illustrations include some of the components of the pump mechanism, including a first reservoir 120, a plunger 121 of the first reservoir, a syringe 130, a syringe plunger 131, a syringe locking portion 148, a sleeve 171, and a valve mechanism 160. The syringe 130 moves in the direction of the thick dashed arrow to the left of the syringe 130, the syringe plunger 131 moves within the syringe 130 in the direction of the thick dashed arrow, the syringe locking portion 148 moves in the direction of the thick solid arrow, and insulin moves in the direction of the thin dashed arrow. Figure 76A shows the first phase of the syringe filling phase, and the pressure in the first reservoir is equal to atmospheric pressure (P). At the start of the syringe filling phase, the syringe 130 moves in the direction of the thick dashed arrow, and a slide needle opening (not shown) moves from the discharge chamber to the injection chamber (Figure 55). Figure 76B shows the end of the movement of the syringe 130 within the sleeve 171. At this stage, the syringe plunger 131 moves within the syringe in the direction of the thick dashed arrow, and insulin moves from the first reservoir 120 to the syringe 130 in the direction of the thin dashed arrow. The pressure in the first reservoir 120 decreases to below atmospheric pressure (P-). Figure 77A shows the end of the syringe filling phase, where the syringe plunger 131 reaches the most proximal position within the syringe 130, the filling of insulin (in the direction of the thin dashed arrow) is complete, and the pressure in the first reservoir 120 is negative (P-). Figure 77B shows the start of the syringe discharge phase. Before the syringe plunger 131 starts to move in the direction of the thick dashed arrow, the syringe locking portion 148 moves in the direction of the thick solid arrow. Following the movement of the syringe locking portion 148, the syringe locking portion 148 engages with the syringe 130, restricting the movement of the syringe. As the syringe plunger 131 further moves within the syringe 130, insulin moves in the direction of the thin dashed arrow and returns into the first reservoir 120. The pressure in the first reservoir 120 increases to above atmospheric pressure (P+). Figure 78A shows the continuation of the reservoir discharge phase. The syringe locking portion 148 moves in the direction of the thick solid arrow, releasing the lock on the syringe 130.The medicator 130 moves within the sleeve 171, and the slide needle opening moves from the injection chamber to the discharge chamber (not shown, see FIG. 56). The pressure in the first reservoir is positive (P+). FIG. 78A shows the next stage of the reservoir discharge phase. The medicator plunger 131 moves in the direction of the thick dashed arrow, and insulin is delivered (thin dashed arrow) through an outlet (not shown) into the patient. The pressure in the first reservoir 120 is above atmospheric pressure (P+). FIG. 79 shows the end of the operating cycle. The medicator 130 and the medicator plunger 131 are placed in the most distal position, where a new operating cycle begins (FIG. 76A).

[0147] FIGS. 80-83 show a partial configuration of a preferred embodiment of a medicator locking portion according to some embodiments. The medicator locking portion can be moved in one direction (locking the movement of the medicator) or in the opposite direction (releasing the movement of the medicator) by an actuator. The actuator can be of any type known in the art, such as, for example, a nitinol wire, a hydraulic pressure, a solenoid, a piezoelectric, a DC motor, etc. FIG. 80 shows an example of a hydraulic actuator, and FIGS. 81-83 show examples of nitinol wire actuators. For example, in some embodiments, FIGS. 80A-B show cross-sectional views of a hydraulic medicator locking mechanism. FIG. 80 shows the first reservoir 120, the motor 42, the medicator 130, the medicator locking portion 148, and the conduit 149 of the medicator locking portion. The conduit 149 of the medicator locking portion is in hydraulic communication with a first conduit (not shown) that communicates between the first reservoir and the injection chamber. During the medicator filling phase (FIGS. 76B and 77A), the pressure in the manifold decreases until it is below atmospheric pressure (FIG. 80A). Following the decrease in the manifold pressure and the decrease in the pressure in the conduit 149 of the medicator locking portion, the medicator locking portion 148 moves in the direction of the thick dashed arrow, and the medicator locking portion 148 engages with the medicator 130, restricting the movement of the medicator 130. At the start of the medicator discharge phase (FIG. 77B), the pressure in the manifold and the pressure in the conduit 149 of the medicator locking portion increase above atmospheric pressure (FIG. 80B), the medicator locking portion 148 moves in the direction of the thick dashed arrow, the medicator locking portion 148 disengages from the medicator 130, and the medicator 130 can move freely.

[0148] Figures 81A - B show a cross - sectional view (Figure 81A) and a space view (Figure 81B) of a mechanical dosing device locking mechanism, which is a spring locking mechanism, according to some embodiments. Figure 81 shows a dosing device 130, a dosing device plunger 131, an O - ring 170 of the DP - RP, a sleeve cover 173, a sleeve cover protrusion 174, a scraper spring 175, a sleeve spring locking part 155, and a notch 1555 of the sleeve spring locking part. The sleeve spring locking part 155 is connected to the dosing device 130. During the dosing device filling phase, the dosing device moves in the direction of the thick dashed line X (Figures 76B and 77A), and when the tip of the sleeve spring locking part 155 reaches the notch 1555 of the sleeve spring locking part, the dosing device 130 is locked and cannot move. During the start of the dosing device discharging phase (Figure 77B), the dosing device plunger 131 moves in the direction of the thick dashed line Y (Figures 78A and 78B). When the dosing device plunger 131 moves further in the same direction, the dosing device scraper spring 175 engages with the dosing device locking part spring 155, the dosing device locking part spring 155 twists, the tip of the actor locking part spring 155 is released from the notch 1555 of the sleeve spring locking part, and the dosing device 130 can move freely.

[0149] Figures 82A - B show a cross - sectional view (Figure 82A) and a perspective view (Figure 82B) of a dispenser locking mechanism based on a Nitinol spring 157, according to some embodiments. Figures 82A - B show a dispenser 130, a scraper spring 175, a sleeve 171, a PCB 61, a dispenser locking portion 148, and a Nitinol spring 157. The dispenser spring 157 is made of Nitinol, a nickel - titanium shape - memory alloy. In some embodiments, the spring can be made from any other shape - memory alloy (e.g., Flexinol, etc.). The Nitinol spring 157 is connected to electrical wiring on both sides (not shown). When current is delivered through the Nitinol spring 157, the overall length of the spring shortens (due to the inherent properties of Nitinol), and the dispenser locking portion 148 moves in the direction of the thick dashed arrow X, the dispenser locking portion 148 engages with the dispenser 130, and the movement of the dispenser 130 is restricted. When the power supply of the current is cut off, the Nitinol spring 157 returns to its original length, the dispenser locking portion 148 moves in the direction of the thick dashed arrow Y, the dispenser locking portion 148 disengages from the dispenser 130, and the dispenser 130 can move freely.

[0150] Figure 83 shows a perspective view of a dispenser locking mechanism based on a Nitinol wire 156, according to some embodiments. Figure 83 shows a PCB 61, a dispenser 130, a dispenser locking portion 148, and a Nitinol wire 156. The Nitinol wire 156 is connected to electrical wiring on both sides (not shown). When current is delivered through the Nitinol wire 156, the overall length of the spring shortens (due to the inherent properties of Nitinol), and the dispenser locking portion 148 moves in the direction of the thick dashed arrow X, the dispenser locking portion 148 engages with the dispenser 130, and the movement of the dispenser 130 is restricted. When the power supply of the current is cut off, the Nitinol wire 155 returns to its original length, the dispenser locking portion 148 moves in the direction of the thick dashed arrow Y, the dispenser locking portion 148 disengages from the dispenser 130, and the dispenser 130 can move freely.

[0151] Although various embodiments of the invention have been described and illustrated herein, those skilled in the art will readily conceive of various other means and / or structures for performing the functions described herein and / or obtaining one or more of the results and / or advantages thereof, and each such variation and / or modification is to be regarded as within the scope of the embodiments of the invention described herein. Further, in general, all parameters, dimensions, materials, and configurations described herein are meant to be examples, and the actual parameters, dimensions, materials, and / or configurations will depend on the specific one or more applications in which the teachings of the invention are used, which will be readily understood by those skilled in the art. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Accordingly, the foregoing embodiments are presented by way of example only, and it is to be understood that the embodiments of the invention may be practiced otherwise than as specifically described within the scope of the appended claims and their equivalents. Embodiments of the invention disclosed herein are directed to each individual feature, system, article, material, kit, and / or method described herein. Additionally, such features, systems, articles, materials, kits, and / or methods may be combined in two or more if they are not mutually inconsistent, and such combinations are also within the scope of the invention disclosed herein.

[0152] Also, the various inventive concepts can be embodied in one or more ways, and examples thereof have been provided. The acts performed as part of the method can be ordered in any suitable way. Accordingly, embodiments may be constructed so that the acts are performed in an order different than illustrated, including having some acts performed simultaneously, even though some acts are shown as sequential in the illustrated embodiments.

[0153] At least a part of the embodiments disclosed above, particularly at least a part of the methods / processes disclosed, may be implemented in circuits, computer hardware, firmware, software, and combinations thereof (e.g., computer systems). Such computing systems may include a PC (which may include one or more peripherals well-known in the art), a smartphone, a specially designed medical device / apparatus, and / or other mobile / portable devices / apparatus. In some embodiments, the computer system is configured to include a client and a server. The client and the server are generally separated from each other and usually interact through a communication network (e.g., VPN, Internet). The relationship between the client and the server is created by computer programs that are executed on their respective computers and have a client-server relationship with each other.

[0154] Some embodiments of the disclosure (e.g., the methods and processes disclosed above) may be embodied in computer programs / instructions that are executable and / or interpretable on a processor and may be connected to other devices (e.g., input devices and output devices / displays) that communicate via, for example, a wireless connection or a wired connection.

[0155] All references to publications or other documents, including but not limited to patents, patent applications, treatises, web pages, books, etc., presented anywhere in this application are hereby incorporated by reference in their entirety. Further, all definitions defined and used in this specification should be understood to take precedence over dictionary definitions, definitions of incorporated references, and / or the ordinary meaning of the defined terms.

[0156] As used herein, the indefinite articles "a" and "an" in the specification and in the claims are to be understood to mean "at least one" unless explicitly indicated to the contrary.

[0157] As used herein, the expression "and / or" in the specification and claims means "either or both" of the elements so connected, i.e., the elements that exist conjunctively in some cases and disjunctively in other cases should be understood. The plurality of elements listed using "and / or" should be construed in the same manner, i.e., "one or more" of the elements so connected. Other elements other than those specifically identified by the "and / or" clause can optionally exist regardless of whether they are related to this specifically identified element or not. Thus, by way of non-limiting example, a reference to "A and / or B" when used with an open-ended term such as "comprising" can, in one embodiment, refer to only A (optionally including elements other than B), in another embodiment, refer to only B (optionally including elements other than A), and in yet another embodiment, refer to both A and B (optionally including other elements), etc.

[0158] As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, a discrete item "or" or "and / or" in a list should be construed as inclusive, i.e., including at least one of several elements or a list of elements, but also two or more, and optionally further items not listed. Only terms that clearly indicate the contrary, such as "only one of" or "exactly one of", or "consisting of" as used in the claims, refer to the inclusion of exactly one element of several elements or a list of elements. Generally, the term "or" as used herein should be construed to indicate exclusive alternatives (i.e., "one or the other but not both") only when preceded by exclusive terms such as "either", "only one of", "only one of", or "exactly one of". "Consisting essentially of" as used in the claims shall have the ordinary meaning as used in the field of patent law.

[0159] As used herein in the specification and in the claims, the expression "at least one" with respect to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but does not necessarily include at least one of every element specifically recited in the list of elements, nor does it exclude any combination of elements in the list of elements. Further, this definition allows for the possibility that other elements, in addition to those specifically identified, may optionally exist in the list of elements to which the expression "at least one" refers, regardless of whether or not they are related to the specifically identified elements. Thus, by way of non-limiting example, "at least one of A and B" (or equivalently "at least one of A or B", or equivalently "at least one of A and / or B") can, in one embodiment, refer to at least one (optionally including two or more) of A, provided that no B exists (optionally including elements other than B), in another embodiment, refer to at least one (optionally including two or more) of B, provided that no A exists (optionally including elements other than A), and in yet another embodiment, refer to at least one (optionally including two or more) of A and at least one (optionally including two or more) of B (optionally including other elements), and so on.

[0160] All transitional phrases in the claims and the above specification, e.g., "comprising", "including", "carrying", "having", "containing", "involving", "holding", "composed of", and the like, are to be understood as open-ended, i.e., meaning including without limitation. Only the transitional phrases "consisting of" and "consisting essentially of" are to be regarded as closed or semi-closed transitional phrases, respectively, as described in section 2111.03 of the Patent Examination Guidelines of the United States Patent and Trademark Office.

Claims

【Claim 1】 The invention described in this specification.

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